Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension
Phase 2
Completed
- Conditions
- Hypertension, Pulmonary
- Interventions
- Registration Number
- NCT02223481
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Terbogrel low dose Terbogrel low dose - Terbogrel high dose Terbogrel high dose - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in pulmonary vascular resistance (PVR) baseline, after 3 months of treatment Change in distance walked in 6 minutes baseline, after 3 months of treatment
- Secondary Outcome Measures
Name Time Method Change in pulmonary artery pressure (PAP) baseline, after 3 months of treatment Change in chronic heart failure index baseline, after 3 months of treatment questionnaire
Change in quality of life by SF-36 questionnaire baseline, after 3 months of treatment Change in cardiac index (CI) baseline, after 3 months of treatment Change in venous oxygen saturation (SvO2 sat.) baseline, after 3 months of treatment Change in dyspnea/fatigue rating baseline, after 3 months of treatment