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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Bosentan

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)