Status:
TERMINATED
Safety of Terbogrel in Patients With Primary Pulmonary Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
Phase:
PHASE2
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-blin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02223494
Start Date
October 1 1998
Last Update
August 22 2014
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