<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/NCT03016468</url>
  </required_header>
  <id_info>
    <org_study_id>TDE-PH-207</org_study_id>
    <nct_id>NCT03016468</nct_id>
  </id_info>
  <brief_title>Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH</brief_title>
  <official_title>A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United Therapeutics</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>
      This is a multicenter, single-arm trial to evaluate the safety of the transition from&#xD;
      Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary&#xD;
      Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10&#xD;
      clinical trial centers. The treatment phase of the study will last approximately 16 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>Phase 2</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>Incidence of Adverse Events (AEs) through 16 Weeks</measure>
    <time_frame>16 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>Parenteral Remodulin then Oral Treprostinil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parenteral Remodulin (treprostinil) injection</intervention_name>
    <description>Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.</description>
    <arm_group_label>Parenteral Remodulin then Oral Treprostinil</arm_group_label>
    <other_name>Remodulin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Treprostinil</intervention_name>
    <description>Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.</description>
    <arm_group_label>Parenteral Remodulin then Oral Treprostinil</arm_group_label>
    <other_name>Orenitram</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated&#xD;
             with connective tissue disease, PAH associated with HIV infection, PAH associated with&#xD;
             repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with&#xD;
             respect to the date of providing informed consent), or PAH associated with appetite&#xD;
             suppressant or toxin use.&#xD;
&#xD;
          2. The subject must be classified as WHO FC II or III at Baseline.&#xD;
&#xD;
          3. The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum&#xD;
             of 90 days from Baseline.&#xD;
&#xD;
          4. Subject is in need of escalation of therapy, as determined by the Investigator.&#xD;
&#xD;
          5. Subject must be receiving a Food and Drug Administration (FDA)-approved PDE5-I or sGC&#xD;
             stimulator and/or an ERA and has been at the current stable dose for at least 28 days&#xD;
             prior to Baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is receiving selexipag for any other disease or condition other than the&#xD;
             treatment of WHO Group 1 PAH.&#xD;
&#xD;
          2. The subject has a Baseline 6MWD of less than 150 meters.&#xD;
&#xD;
          3. The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag&#xD;
             baseline.&#xD;
&#xD;
          4. The subject has a history of ischemic heart disease (defined as either symptomatic or&#xD;
             requiring anti-anginal therapy or experienced a documented myocardial infarction&#xD;
             within the previous 6 months of Baseline), or a history of left sided myocardial&#xD;
             dysfunction as evidenced by a PAWP greater than 15 mmHg or a left ventricular ejection&#xD;
             fraction less than 40%.&#xD;
&#xD;
          5. The subject has previously been treated with any parenteral prostacyclin or oral&#xD;
             treprostinil for a period of 90 days or more.&#xD;
&#xD;
          6. The subject has a history of 1 or more of the following signs of relevant lung disease&#xD;
             within 180 days before Baseline:&#xD;
&#xD;
               1. Total lung capacity less than 60% of predicted normal.&#xD;
&#xD;
               2. Forced expiratory volume in 1 second is less than 55% of predicted normal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Treprostinil</keyword>
  <keyword>Remodulin</keyword>
  <keyword>Selexipag</keyword>
  <keyword>6 Minute Walk Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Treprostinil</mesh_term>
  </intervention_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/NCT03016468
org study id: TDE-PH-207
nct id: NCT03016468
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, single-arm trial to evaluate the safety of the transition from
      Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary
      Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10
      clinical trial centers. The treatment phase of the study will last approximately 16 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Adverse Events (AEs) through 16 Weeks
time frame: 16 Weeks
measure: Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16
time frame: Baseline and Week 16
measure: Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16
time frame: Baseline and Week 16
measure: Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16
time frame: Baseline and Week 16
measure: Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16
time frame: Baseline and Week 16
measure: Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16
time frame: Baseline and Week 16
arm group label: Parenteral Remodulin then Oral Treprostinil
arm group type: Experimental
intervention type: Drug
intervention name: Parenteral Remodulin (treprostinil) injection
description: Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.
arm group label: Parenteral Remodulin then Oral Treprostinil
other name: Remodulin
intervention type: Drug
intervention name: Oral Treprostinil
description: Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.
arm group label: Parenteral Remodulin then Oral Treprostinil
other name: Orenitram
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
mesh term: Treprostinil