Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Actelion0 sites157 target enrollmentOctober 2005

ConditionsChronic Thromboembolic Pulmonary Hypertension

Drugsbosentan

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Sponsor: Actelion
Enrollment: 157
Primary Endpoint: Change from Baseline to Week 16 in 6-Minute Walk Test distance
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

March 2007

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Actelion

Eligibility Criteria

Inclusion Criteria

•Symptomatic pulmonary hypertension in modified NYHA functional class II to IV due to CTEPH as demonstrated by ventilation/perfusion lung scanning and pulmonary angiography.
•CTEPH judged inoperable because of peripheral localization of thrombotic material or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy (PEA) with no evidence of recurrent thromboembolism and not amenable to repeated surgery.
•6-minute walk test (6MWT) distance \< 450 m.
•Hemodynamic evaluation showing: Mean pulmonary arterial pressure (mPAP) \>= 25 mmHg; Pulmonary capillary wedge pressure (PCWP) \< 15 mmHg; Pulmonary vascular resistance (PVR) at rest \>= 300 dyn×sec/cm5
•For patients who underwent PEA, hemodynamic evaluation must have been performed more than 6 months after PEA.
•For all patients, hemodynamic evaluation must have been performed with the 3 months immediately preceding inclusion.
•Men or women \>= 18 and =\< 80 years of age (Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception).
•Anticoagulants at efficacious dose for at least 3 months prior to randomization.
•Signed informed consent prior to initiation of any study-mandated procedure.

Exclusion Criteria

•Other forms of pulmonary hypertension including pulmonary hypertension related to sickle cell disease.
•Obstructive lung disease: FEV1/FVC \< 0.5 after bronchodilator.
•Severe restrictive lung disease: Total Lung Capacity \< 60% of predicted value.
•Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6MWT), e.g., angina pectoris, intermittent claudication.
•Symptomatic pulmonary embolism within 6 months prior to randomization.
•Pulmonary endarterectomy within 6 months prior to randomization.
•Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
•Illness with a life expectancy of less than 6 months.
•Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
•AST and/or ALT \> 3 times the upper limit of normal ranges.· Hemoglobin concentration \< 75% the lower limit of normal ranges.