NCT00091715CompletedPhase 3
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 enrollmentStarted: April 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 185
- Locations
- 33
- Primary Endpoint
- exercise capacity
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
1
Experimental
62.5 mg table twice a day for 4 weeks followed by 125 mg tablet twice a day for 6 months followed by an open label period until end of study.
Intervention: bosentan (Drug)
2
Placebo Comparator
placebo for 6 months followed by an open label period
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
exercise capacity
Time Frame: Baseline to end of study
cardiac hemodynamics
Time Frame: Baseline to end of study
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (33)
Loading locations...
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