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Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

Primary Purpose

Hypertension, Pulmonary

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Terbogrel low dose

Terbogrel high dose

Placebo

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Terbogrel low dose

Terbogrel high dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in distance walked in 6 minutes

Change in pulmonary vascular resistance (PVR)

Secondary Outcome Measures

Change in pulmonary artery pressure (PAP)

Change in cardiac index (CI)

Change in venous oxygen saturation (SvO2 sat.)

Change in quality of life by SF-36 questionnaire

Change in chronic heart failure index

questionnaire

Change in dyspnea/fatigue rating

Full Information

NCT ID

NCT02223481

First Posted

August 21, 2014

Last Updated

August 21, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02223481

Brief Title

Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

May 1998 (undefined)

Primary Completion Date

September 1999 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Terbogrel low dose

Arm Type

Experimental

Arm Title

Terbogrel high dose

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Terbogrel low dose

Intervention Type

Drug

Intervention Name(s)

Terbogrel high dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in distance walked in 6 minutes

Time Frame