Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Hypertension, Pulmonary

Treatments: Drug: Terbogrel low dose; Drug: Placebo; Drug: Terbogrel high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02223481

528.19

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

71 participants in 3 patient groups, including a placebo group

Terbogrel low dose

Experimental group

Treatment:

Drug: Terbogrel low dose

Terbogrel high dose

Experimental group

Treatment:

Drug: Terbogrel high dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo