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Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

Primary Purpose

Hypertension, Pulmonary

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Terbogrel
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who

  • completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19)
  • provide informed consent to participate in this trial
  • are in a stable or improving medical condition, in the opinion of the investigator
  • enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim

Exclusion Criteria:

  • Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel
  • Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason
  • Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Terbogrel

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of patients with adverse events
    Number of patients with clinically significant findings in laboratory tests
    Number of patients with clinically significant changes in ECG

    Secondary Outcome Measures

    Change in patient status
    change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death

    Full Information

    First Posted
    August 21, 2014
    Last Updated
    August 21, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02223494
    Brief Title
    Safety of Terbogrel in Patients With Primary Pulmonary Hypertension
    Official Title
    An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Terminated
    Study Start Date
    October 1998 (undefined)
    Primary Completion Date
    March 2000 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief Summary
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Pulmonary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Terbogrel
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Terbogrel
    Primary Outcome Measure Information:
    Title
    Number of patients with adverse events
    Time Frame
    up to 18 months
    Title
    Number of patients with clinically significant findings in laboratory tests
    Time Frame
    up to 18 months
    Title
    Number of patients with clinically significant changes in ECG
    Time Frame
    up to 18 months
    Secondary Outcome Measure Information:
    Title
    Change in patient status
    Description
    change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death
    Time Frame
    baseline, up to 18 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19) provide informed consent to participate in this trial are in a stable or improving medical condition, in the opinion of the investigator enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim Exclusion Criteria: Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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    Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

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