Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02223494
• Other study ID #: 528.21
• Status: Terminated
• Phase: Phase 2
• First received: August 21, 2014
• Last updated: August 21, 2014
• Start date: October 1998

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesSwitzerland: Federal Office of Public HealthFrance: Agence Nationale de Sécurité du Médicament et des produits de santéBelgium: Federal Agency for Medicines and Health Products, FAMHPUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Terbogrel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		up to 18 months	No
Primary	Number of patients with clinically significant findings in laboratory tests		up to 18 months	No
Primary	Number of patients with clinically significant changes in ECG		up to 18 months	No
Secondary	Change in patient status	change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death	baseline, up to 18 months	No

External Links

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