Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

A Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Drug: Placebo; Drug: Terbogrel low dose; Drug: Terbogrel high dose

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Terbogrel low dose	Drug: Terbogrel low dose
Experimental: Terbogrel high dose	Drug: Terbogrel high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in distance walked in 6 minutes	baseline, after 3 months of treatment
Change in pulmonary vascular resistance (PVR)	baseline, after 3 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulmonary artery pressure (PAP)		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 quality of life by SF-36 questionnaire		baseline, after 3 months of treatment
Change in chronic heart failure index	questionnaire	baseline, after 3 months of treatment
Change in dyspnea/fatigue rating		baseline, after 3 months of treatment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 1998
• Primary Completion (Actual): September 1, 1999

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 528.19