<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/NCT02223494</url>
  </required_header>
  <id_info>
    <org_study_id>528.21</org_study_id>
    <nct_id>NCT02223494</nct_id>
  </id_info>
  <brief_title>Safety of Terbogrel in Patients With Primary Pulmonary Hypertension</brief_title>
  <official_title>An Open-label, Long-term Safety Evaluation 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>
      Study to assess the safety of terbogrel during open-label, long-term treatment in medically&#xD;
      stable or improving patients with primary pulmonary hypertension who have completed the&#xD;
      12-week, double-blind randomized trial of terbogrel (protocol 528.19)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>October 1998</start_date>
  <primary_completion_date type="Actual">March 2000</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>Number of patients with adverse events</measure>
    <time_frame>up to 18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant changes in ECG</measure>
    <time_frame>up to 18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in patient status</measure>
    <time_frame>baseline, up to 18 months</time_frame>
    <description>change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <arm_group>
    <arm_group_label>Terbogrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Terbogrel</intervention_name>
    <arm_group_label>Terbogrel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who&#xD;
&#xD;
          -  completed the preceding primary pulmonary hypertension, double-blinded clinical trial&#xD;
             of terbogrel (protocol 528.19)&#xD;
&#xD;
          -  provide informed consent to participate in this trial&#xD;
&#xD;
          -  are in a stable or improving medical condition, in the opinion of the investigator&#xD;
&#xD;
          -  enter the study immediately upon their completion of the preceding double-blind Trial&#xD;
             528.19, or enter the study within one month of completing the preceding trial as long&#xD;
             as their medical condition has remained stable or continues to improve in the interim&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Development of an unstable medical condition during or following completion of the&#xD;
             preceding clinical trial which, in the investigator's opinion, may be worsened by&#xD;
             treatment with terbogrel&#xD;
&#xD;
          -  Premature discontinuation of the preceding terbogrel clinical trial due to an adverse&#xD;
             event or for any other reason&#xD;
&#xD;
          -  Pregnant or nursing women, or women of childbearing potential (less than one year&#xD;
             postmenopausal or not surgically sterilized) who are not using adequate methods of&#xD;
             birth control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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/NCT02223494
org study id: 528.21
nct id: NCT02223494
lead sponsor: 
Study to assess the safety of terbogrel during open-label, long-term treatment in medically
      stable or improving patients with primary pulmonary hypertension who have completed the
      12-week, double-blind randomized trial of terbogrel (protocol 528.19)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with adverse events
time frame: up to 18 months
measure: Number of patients with clinically significant findings in laboratory tests
time frame: up to 18 months
measure: Number of patients with clinically significant changes in ECG
time frame: up to 18 months
measure: Change in patient status
time frame: baseline, up to 18 months
description: change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death
arm group label: Terbogrel
arm group type: Experimental
intervention type: Drug
intervention name: Terbogrel
arm group label: Terbogrel
criteria: 
gender: All
minimum age: N/A
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