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

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: placebo; Drug: bosentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091715

AC-052-364

EARLY

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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185 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Drug: bosentan

2

Placebo Comparator group

Description:

placebo for 6 months followed by an open label period

Treatment:

Drug: placebo