<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/NCT02223481</url>
  </required_header>
  <id_info>
    <org_study_id>528.19</org_study_id>
    <nct_id>NCT02223481</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      This study sought to determine whether terbogrel was an effective treatment for primary&#xD;
      pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 1998</start_date>
  <primary_completion_date type="Actual">September 1999</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in distance walked in 6 minutes</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pulmonary vascular resistance (PVR)</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary artery pressure (PAP)</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac index (CI)</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in venous oxygen saturation (SvO2 sat.)</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life by SF-36 questionnaire</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in chronic heart failure index</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dyspnea/fatigue rating</measure>
    <time_frame>baseline, after 3 months of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <arm_group>
    <arm_group_label>Terbogrel low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Terbogrel high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Terbogrel low dose</intervention_name>
    <arm_group_label>Terbogrel low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Terbogrel high dose</intervention_name>
    <arm_group_label>Terbogrel high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary pulmonary hypertension and New York Health Association (NYHA) chronic heart&#xD;
             failure (CHF) functional class II-III&#xD;
&#xD;
          -  Ability to walk &gt;= 50 meters on the 6 minute walk test&#xD;
&#xD;
          -  Resting mean pulmonary artery pressure &gt; 25 mmHg&#xD;
&#xD;
          -  Mean right atrial pressure &lt;= 20 mmHg&#xD;
&#xD;
          -  Pulmonary capillary wedge pressure &lt;= 15 mmHg&#xD;
&#xD;
          -  Cardiac index &gt; 2.5 L/min2&#xD;
&#xD;
          -  SvO2 sat. &gt; 63%&#xD;
&#xD;
          -  Male of female at least 18 years old&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary pulmonary hypertension due to lung or systemic diseases&#xD;
&#xD;
          -  Pregnant of nursing women, or women of childbearing potential who are not using&#xD;
             adequate methods of birth control&#xD;
&#xD;
          -  Concurrent systematic use of aspirin, aspirin like drugs, or non-steroidal&#xD;
             anti-inflammatory drugs (NSAIDs)&#xD;
&#xD;
          -  Surgery of bleeding from gastrointestinal, genitourinary tract, cerebrum or retina&#xD;
             within past 6 weeks&#xD;
&#xD;
          -  History of bleeding diathesis or a platelet count less than 70,000/mm3&#xD;
&#xD;
          -  Exercise limited by factors other than fatigue or exertional dyspnea, such as&#xD;
             arthritis, claudication, angina, chronic obstructive pulmonary disease, or bronchial&#xD;
             asthma&#xD;
&#xD;
          -  Myocardial infarction, stroke, or transient ischemic attack within the preceding six&#xD;
             months&#xD;
&#xD;
          -  Systolic blood pressure &lt; 90 mmHg or &gt; 180 mmHg, or diastolic blood pressure &gt; 110&#xD;
             mmHg&#xD;
&#xD;
          -  Known drug or alcohol dependency within one year of entry into the study&#xD;
&#xD;
          -  Known hypersensitivity to any component of the study formulation, epoprostenol, nitric&#xD;
             oxide, or adenosine&#xD;
&#xD;
          -  Psychiatric or other illness or condition which, in the opinion of the principal&#xD;
             investigator, may interfere with study participation, compliance, or other elements of&#xD;
             the protocol&#xD;
&#xD;
          -  Participation in an evaluation of an investigational drug within the past 30 days&#xD;
&#xD;
          -  Portal hypertension or cirrhosis of the liver&#xD;
&#xD;
          -  Congenital heart disease e.g., atrial septal defect; patent foramen ovale does not&#xD;
             exclude patient from the study&#xD;
&#xD;
          -  Appetite suppressants such as fenfluramine, dexfenfluramine, and inhibitors of&#xD;
             serotonin uptake known to be associated with primary pulmonary hypertension, received&#xD;
             within 3 months of entry into the study&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Vasodilators. Patients will not receive Ca-channel blockers during the study unless&#xD;
             the medication was started prior to the study and the patient has been on a stable&#xD;
             dose for at least one month prior to entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02223481
org study id: 528.19
nct id: NCT02223481
lead sponsor: 
This study sought to determine whether terbogrel was an effective treatment for primary
      pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change in distance walked in 6 minutes
time frame: baseline, after 3 months of treatment
measure: Change in pulmonary vascular resistance (PVR)
time frame: baseline, after 3 months of treatment
measure: Change in pulmonary artery pressure (PAP)
time frame: baseline, after 3 months of treatment
measure: Change in cardiac index (CI)
time frame: baseline, after 3 months of treatment
measure: Change in venous oxygen saturation (SvO2 sat.)
time frame: baseline, after 3 months of treatment
measure: Change in quality of life by SF-36 questionnaire
time frame: baseline, after 3 months of treatment
measure: Change in chronic heart failure index
time frame: baseline, after 3 months of treatment
description: questionnaire
measure: Change in dyspnea/fatigue rating
time frame: baseline, after 3 months of treatment
arm group label: Terbogrel low dose
arm group type: Experimental
arm group label: Terbogrel high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Terbogrel low dose
arm group label: Terbogrel low dose
intervention type: Drug
intervention name: Terbogrel high dose
arm group label: Terbogrel high dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension