Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

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