Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study sought to determine whether terbogrel was an effective treatment for primary pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• Primary pulmonary hypertension and New York Health Association (NYHA) chronic heart failure (CHF) functional class II-III

• Ability to walk >= 50 meters on the 6 minute walk test

• Resting mean pulmonary artery pressure > 25 mmHg

• Mean right atrial pressure <= 20 mmHg

• Pulmonary capillary wedge pressure <= 15 mmHg

• Cardiac index > 2.5 L/min2

• SvO2 sat. > 63%

• Male of female at least 18 years old

• Signed written informed consent

Exclusion Criteria:

• Secondary pulmonary hypertension due to lung or systemic diseases

• Pregnant of nursing women, or women of childbearing potential who are not using adequate methods of birth control

• Concurrent systematic use of aspirin, aspirin like drugs, or non-steroidal anti-inflammatory drugs (NSAIDs)

• Surgery of bleeding from gastrointestinal, genitourinary tract, cerebrum or retina within past 6 weeks

• History of bleeding diathesis or a platelet count less than 70,000/mm3

• Exercise limited by factors other than fatigue or exertional dyspnea, such as arthritis, claudication, angina, chronic obstructive pulmonary disease, or bronchial asthma

• Myocardial infarction, stroke, or transient ischemic attack within the preceding six months

• Systolic blood pressure < 90 mmHg or > 180 mmHg, or diastolic blood pressure > 110 mmHg

• Known drug or alcohol dependency within one year of entry into the study

• Known hypersensitivity to any component of the study formulation, epoprostenol, nitric oxide, or adenosine

• Psychiatric or other illness or condition which, in the opinion of the principal investigator, may interfere with study participation, compliance, or other elements of the protocol

• Participation in an evaluation of an investigational drug within the past 30 days

• Portal hypertension or cirrhosis of the liver

• Congenital heart disease e.g., atrial septal defect; patent foramen ovale does not exclude patient from the study

• Appetite suppressants such as fenfluramine, dexfenfluramine, and inhibitors of serotonin uptake known to be associated with primary pulmonary hypertension, received within 3 months of entry into the study

• HIV positive

• Vasodilators. Patients will not receive Ca-channel blockers during the study unless the medication was started prior to the study and the patient has been on a stable dose for at least one month prior to entry