Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02223494

Enrollment

Registered

2014-08-22

Start date

1998-10-31

Completion date

Unknown

Last updated

2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

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)

Interventions

DRUGTerbogrel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026