Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

Boehringer Ingelheim

Status and phase

Terminated

Phase 2

Conditions

Hypertension, Pulmonary

Treatments

Drug: Terbogrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02223494

528.21

Details and patient eligibility

About

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)

Enrollment

33 patients

Sex

All

Volunteers

No 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