Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II

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.

Official Title

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)

Conditions

Pulmonary Hypertension

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcomes: exercise capacity; cardiac hemodynamics

Study Start

September 2004

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 distanceExclusion 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)

Total Enrolment

Contact Details

The Prince Charles Hospital, Brisbane, 4032, Australia; RecruitingKeith McNeil, MD +61(0)7335081111 keith_mcneil@health.gld.gov.au The Alfred Hospital, Melbourne, 3004, Australia; RecruitingTrevor Williams, MD +61(0)395292489 t.williams@alfred.org.au