A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)

Actelion33 sites in 14 countries185 target enrollmentApril 2004

ConditionsPulmonary Hypertension

Interventionsbosentan placebo

Drugsbosentan placebo

Overview

Phase: Phase 3
Intervention: bosentan
Conditions: Pulmonary Hypertension
Sponsor: Actelion
Enrollment: 185
Locations: 33
Primary Endpoint: exercise capacity
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites 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) Class III and IV, to patients suffering from PAH Class II.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

February 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Actelion

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•PAH NYHA Class II
•Significant elevation of mean pulmonary arterial pressure
•Significant elevation of pulmonary vascular resistance at rest
•Limited 6-minute walk distance

Exclusion Criteria

•PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt
•Restrictive or obstructive lung disease
•Significant vasoreactivity
•Treatments for PAH (within 4 weeks of randomization)