<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02191137</url>
  </required_header>
  <id_info>
    <org_study_id>17407</org_study_id>
    <nct_id>NCT02191137</nct_id>
  </id_info>
  <brief_title>Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)</brief_title>
  <official_title>A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial&#xD;
      Hypertension (PAH). The study was designed to further explore patient-reported outcomes in&#xD;
      PAH subjects who were not on active treatment and living in the United States. In addition,&#xD;
      the study explored the use of new telemetric technology (Accelerator band) to evaluate if&#xD;
      this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients&#xD;
      with PAH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2014</start_date>
  <completion_date type="Actual">July 16, 2016</completion_date>
  <primary_completion_date type="Actual">July 16, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 4 and 16 in the LPH Total Score</measure>
    <time_frame>Baseline to Week 4 and Week 16</time_frame>
    <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score</measure>
    <time_frame>Baseline to Weeks 4, 16, and 24</time_frame>
    <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>For LPH total score, the MCID was an 11-point decrease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class</measure>
    <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
    <description>Functional class was determined by the WHO classification:&#xD;
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.&#xD;
In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>Functional class was determined by the WHO classification:&#xD;
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst). In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Weeks 16 and 24 in the 6MWD</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)</measure>
    <time_frame>Week 16 to Week 24</time_frame>
    <description>Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <arm_group>
    <arm_group_label>Riociguat 0.5mg to 2.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm, open label</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Riociguat (Adempas, BAY63-2521)</intervention_name>
    <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
    <arm_group_label>Riociguat 0.5mg to 2.5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients, 18 to 80 years of age at Visit 0&#xD;
&#xD;
          -  Women of childbearing potential must have a negative pre-treatment pregnancy test,&#xD;
             negative monthly pregnancy test, and must use reliable methods of contraception&#xD;
             according to the Risk Evaluation Mitigation Strategies (REMS) guidance&#xD;
&#xD;
          -  Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a&#xD;
             pulmonary vascular resistance (PVR) &gt;300 dyn*sec*cm-5, mean pulmonary artery pressure&#xD;
             (PAP mean) ≥25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤15 mmHg as&#xD;
             assessed by right heart catheterization within 6 months prior to Screening (Visit 0)&#xD;
&#xD;
          -  PAH of the following types:&#xD;
&#xD;
        Idiopathic (IPAH) Familial (FPAH)&#xD;
&#xD;
        Associated with PAH (APAH) due to:&#xD;
&#xD;
        Connective tissue disease Congenital heart disease, but only if patient underwent surgical&#xD;
        repair more than one year before enrollment Anorexigen or amphetamine use Portal&#xD;
        hypertension with liver cirrhosis&#xD;
&#xD;
          -  Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit&#xD;
             0)&#xD;
&#xD;
          -  6MWD between 150 meters and 450 meters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients&#xD;
             currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil,&#xD;
             vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)&#xD;
&#xD;
          -  Non-WHO group 1 Pulmonary Hypertension&#xD;
&#xD;
          -  Severe restrictive lung disease&#xD;
&#xD;
          -  History of uncontrolled high blood pressure or hypotension&#xD;
&#xD;
          -  A medical disorder, condition, or history that in the opinion of the Investigator&#xD;
             would impair their ability to participate or complete this study&#xD;
&#xD;
          -  Active state of hemoptysis or pulmonary hemorrhage, including those events managed by&#xD;
             bronchial artery embolization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moreno Valley</city>
        <state>California</state>
        <zip>92553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan Capistrano</city>
        <state>California</state>
        <zip>92675</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Celebration</city>
        <state>Florida</state>
        <zip>34747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austell</city>
        <state>Georgia</state>
        <zip>30106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pascagoula</city>
        <state>Mississippi</state>
        <zip>39581</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <state>New York</state>
        <zip>13088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8172</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903-4900</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guaynabo</city>
        <zip>00968</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <results_first_submitted>July 12, 2017</results_first_submitted>
  <results_first_submitted_qc>September 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 13, 2017</results_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary Hypertension,Riociguat,Living with Pulmonary Hypertension Questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riociguat</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 97 patients signed informed consent; 22 patients did not complete screening (20 patients were screen failures and 2 patients withdrew from the study). Of 75 patients who received therapy with riociguat, 65 patients completed study treatment and entered follow-up, and 60 patients completed the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Riociguat (Adempas, BAY63-2521)</title>
          <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing/unknown</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Riociguat (Adempas, BAY63-2521)</title>
          <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.7" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Living with Pulmonary Hypertension (LPH)</title>
          <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.</description>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Total score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.03" spread="24.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical dimension score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.83" spread="10.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional dimension score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.20" spread="7.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short Form-12 Health Survey (SF-12) questionnaire</title>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Physical component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.660" spread="8.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.453" spread="9.213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>WHO functional class</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Modified Borg Dyspnea Scale</title>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.47" spread="2.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Six-minute walk distance (6MWD)</title>
          <units>Meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="310.259" spread="89.578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Work Limitations Questionnaire (WLQ)</title>
          <description>The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Time management scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.42" spread="30.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical demands scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.47" spread="28.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental-interpersonal demands scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.66" spread="25.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Output demands scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.52" spread="31.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>WLQ: Percentage of Productivity loss</title>
          <description>The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.</description>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.85" spread="6.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score</title>
        <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 66 patients were evaluable for LPH total score at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score</title>
          <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 66 patients were evaluable for LPH total score at Week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.99" spread="22.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 4 and 16 in the LPH Total Score</title>
        <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4 and Week 16</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 4 and 16 in the LPH Total Score</title>
          <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at Week 4.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (N=72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.65" spread="18.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (N=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.98" spread="20.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)</title>
        <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)</title>
          <description>The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.66" spread="15.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score</title>
        <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Weeks 4, 16, and 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH physical dimension score at week 16 or before.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score</title>
          <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH physical dimension score at week 16 or before.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (N=72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.77" spread="8.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 or Last Before (N=75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.97" spread="9.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (N=65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.10" spread="9.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)</title>
        <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for LPH physical dimension score at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)</title>
          <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for LPH physical dimension score at Week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.86" spread="7.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score</title>
        <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH emotional dimension score at week 16 or before.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score</title>
          <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH emotional dimension score at week 16 or before.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (N=72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" spread="5.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 or Last Before (N=75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.44" spread="7.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.33" spread="6.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)</title>
        <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)</title>
          <description>The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="5.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24</title>
        <description>For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24</title>
          <description>For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at week 4.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (N=72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9" lower_limit="0.34" upper_limit="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (N=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6" lower_limit="0.39" upper_limit="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" lower_limit="0.47" upper_limit="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24</title>
        <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH physical dimension score at week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24</title>
          <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH physical dimension score at week 4.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (N=72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (N=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (N=65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24</title>
        <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH emotional dimension score at week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24</title>
          <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH emotional dimension score at week 4.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (N=72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (N=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)</title>
        <description>For LPH total score, the MCID was an 11-point decrease.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)</title>
          <description>For LPH total score, the MCID was an 11-point decrease.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)</title>
        <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients were evaluable for LPH physical dimension score at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)</title>
          <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients were evaluable for LPH physical dimension score at week 24.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)</title>
        <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)</title>
          <description>For the physical and emotional dimension scores, the MCID was a 4-point decrease.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores</title>
        <description>The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 52 patients were evaluable for WLQ at week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores</title>
          <description>The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 52 patients were evaluable for WLQ at week 4.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 Time management score, N=45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.17" spread="25.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 Physical demands score, N=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="25.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 Mental-interpersonal demands score, N=48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.59" spread="25.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 Output demands score, N=40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.88" spread="27.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 Time management score, N=45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="26.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 Physical demands score, N=49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.40" spread="26.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 Mental-interpersonal demands score, N=46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.52" spread="24.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 Output demands score, N=40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" spread="25.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 Time management score, N=42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.68" spread="26.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 Physical demands score, N=43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="21.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 Mental-interpersonal demands score, N=41</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.13" spread="25.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 Output demands score, N=34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.57" spread="25.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss</title>
        <description>The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 37 patients were evaluable for WLQ percentage of productivity loss at week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss</title>
          <description>The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 37 patients were evaluable for WLQ percentage of productivity loss at week 4.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 Productivity loss (%), N=37</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.07" spread="4.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 Productivity loss (%), N=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="4.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 Productivity loss (%), N=27</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="5.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)</title>
        <description>The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)</title>
          <description>The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ at Week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time management score, N=39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="25.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical demands score, N=40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.56" spread="24.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental-interpersonal demands score, N=38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.92" spread="19.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Output demands score, N=34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.78" spread="24.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)</title>
        <description>The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ percentage of productivity loss at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)</title>
          <description>The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ percentage of productivity loss at week 24.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="4.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score</title>
        <description>SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 73 patients were evaluable for PCS and MCS at Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score</title>
          <description>SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 73 patients were evaluable for PCS and MCS at Week 4.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PCS Week 4 (N=73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.009" spread="6.474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS Week 16 (N=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.036" spread="7.059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS Week 24 (N=67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.230" spread="8.401"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS Week 4 (N=73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.955" spread="9.262"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS Week 16 (N=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.869" spread="7.605"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS Week 24 (N=67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.883" spread="10.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)</title>
        <description>SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for PCS and MCS at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)</title>
          <description>SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for PCS and MCS at Week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.383" spread="6.810"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.437" spread="8.378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class</title>
        <description>Functional class was determined by the WHO classification:&#xD;
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.&#xD;
In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Baseline to Week 4, Week 16 and Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for WHO Function Class at Week 16 or Last Before.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class</title>
          <description>Functional class was determined by the WHO classification:&#xD;
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.&#xD;
In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for WHO Function Class at Week 16 or Last Before.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (-1 Change in WHO Class), N=72</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (0 Change in WHO Class), N=72</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (+1 Change in WHO Class), N=72</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (+2 Change in WHO Class), N=72</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 or LastBefore (-1 Change in WHOClass),N=75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 or LastBefore (0 Change in WHOClass),N=75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 or LastBefore (+1 Change in WHOClass),N=75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 or LastBefore (+2 Change in WHOClass),N=75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (-1 Change in WHO Class), N=67</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (0 Change in WHO Class), N=67</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (+1 Change in WHO Class), N=67</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (+2 Change in WHO Class), N=67</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)</title>
        <description>Functional class was determined by the WHO classification:&#xD;
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for WHO Function Class at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)</title>
          <description>Functional class was determined by the WHO classification:&#xD;
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.&#xD;
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for WHO Function Class at Week 24.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>-2 Change in WHO Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1 Change in WHO Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 Change in WHO Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+1 Change in WHO Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+2 Change in WHO Class</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale</title>
        <description>The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst). In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 58 patients were evaluable for Modified Borg Dyspnea Scale at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale</title>
          <description>The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst). In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 58 patients were evaluable for Modified Borg Dyspnea Scale at week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16 (N=57)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (N=58)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.91" spread="3.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)</title>
        <description>The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst).</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for Modified Borg Dyspnea Scale at Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)</title>
          <description>The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst).</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for Modified Borg Dyspnea Scale at Week 24.</population>
          <units>Scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Weeks 16 and 24 in the 6MWD</title>
        <description>Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 67 patients were evaluable for 6MWD at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Weeks 16 and 24 in the 6MWD</title>
          <description>Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, &quot;N&quot; signifies subjects who were evaluable for the specific parameter at that timepoint.</description>
          <population>The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 67 patients were evaluable for 6MWD at week 24.</population>
          <units>Meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16 (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.362" spread="75.506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (N=67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.921" spread="59.247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)</title>
        <description>Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.</description>
        <time_frame>Week 16 to Week 24</time_frame>
        <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for 6MWD at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Riociguat (Adempas, BAY63-2521)</title>
            <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)</title>
          <description>Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.</description>
          <population>The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for 6MWD at week 24.</population>
          <units>Meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.932" spread="71.542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of test drug up to 2 days after the last dose.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Riociguat (Adempas, BAY63-2521)</title>
          <description>Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac resynchronisation therapy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="18" subjects_affected="14" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="15" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>BAYER</organization>
      <email>clinical-trials-contact@bayer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02191137
org study id: 17407
nct id: NCT02191137
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial
      Hypertension (PAH). The study was designed to further explore patient-reported outcomes in
      PAH subjects who were not on active treatment and living in the United States. In addition,
      the study explored the use of new telemetric technology (Accelerator band) to evaluate if
      this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients
      with PAH.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score
time frame: Baseline to Week 24
description: The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.
measure: Change From Baseline to Weeks 4 and 16 in the LPH Total Score
time frame: Baseline to Week 4 and Week 16
description: The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.
measure: Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score
time frame: Baseline to Weeks 4, 16, and 24
description: The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.
measure: Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score
time frame: Baseline to Week 4, Week 16 and Week 24
description: The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.
measure: Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24
time frame: Baseline to Week 4, Week 16 and Week 24
description: For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24
time frame: Baseline to Week 4, Week 16 and Week 24
description: For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24
time frame: Baseline to Week 4, Week 16 and Week 24
description: For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: For LPH total score, the MCID was an 11-point decrease.
measure: Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: For the physical and emotional dimension scores, the MCID was a 4-point decrease.
measure: Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: For the physical and emotional dimension scores, the MCID was a 4-point decrease.
measure: Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores
time frame: Baseline to Week 4, Week 16 and Week 24
description: The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss
time frame: Baseline to Week 4, Week 16 and Week 24
description: The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.
measure: Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.
measure: Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score
time frame: Baseline to Week 4, Week 16 and Week 24
description: SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
measure: Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class
time frame: Baseline to Week 4, Week 16 and Week 24
description: Functional class was determined by the WHO classification:
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: Functional class was determined by the WHO classification:
I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.
III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
measure: Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale
time frame: Week 16 to Week 24
description: The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst). In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst).
measure: Change From Baseline to Weeks 16 and 24 in the 6MWD
time frame: Week 16 to Week 24
description: Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
measure: Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)
time frame: Week 16 to Week 24
description: Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.
arm group label: Riociguat 0.5mg to 2.5 mg
arm group type: Experimental
description: Single arm, open label
intervention type: Drug
intervention name: Riociguat (Adempas, BAY63-2521)
description: Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
arm group label: Riociguat 0.5mg to 2.5 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Riociguat
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