Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

Phase 2

Terminated

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Terbogrel

• Registration Number: NCT02223494
• Lead Sponsor: Boehringer Ingelheim

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)

Detailed Description

Not available

Study Timeline

• Study Start: 1998-10
• Primary Completion: 2000-03
• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-22
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Terbogrel	Terbogrel	-

Primary Outcome Measures

Name	Time	Method
Number of patients with clinically significant findings in laboratory tests	up to 18 months
Number of patients with adverse events	up to 18 months
Number of patients with clinically significant changes in ECG	up to 18 months

Secondary Outcome Measures

Name	Time	Method
Change in patient status	baseline, up to 18 months	change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death