Clinical trial NCT02223481: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in distance walked in 6 minutes
timeFrame: baseline, after 3 months of treatment
measure: Change in pulmonary vascular resistance (PVR)
timeFrame: baseline, after 3 months of treatment
Secondary outcomes:
measure: Change in pulmonary artery pressure (PAP)
timeFrame: baseline, after 3 months of treatment
measure: Change in cardiac index (CI)
timeFrame: baseline, after 3 months of treatment
measure: Change in venous oxygen saturation (SvO2 sat.)
timeFrame: baseline, after 3 months of treatment
measure: Change in quality of life by SF-36 questionnaire
timeFrame: baseline, after 3 months of treatment
measure: Change in chronic heart failure index
timeFrame: baseline, after 3 months of treatment
measure: Change in dyspnea/fatigue rating
timeFrame: baseline, after 3 months of treatment
Other outcomes:
Locations:
Study officials:
References: