Trials / Completed
CompletedNCT00091715
Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bosentan | 65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study |
| DRUG | placebo | placebo for 6 months followed by an open-label period |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2006-11-01
- Completion
- 2011-02-01
- First posted
- 2004-09-20
- Last updated
- 2011-08-30
Locations
34 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00091715. Inclusion in this directory is not an endorsement.