Trials / Completed
CompletedNCT00070590
Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 132 (planned)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosentan |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2005-09-01
- Completion
- 2005-09-01
- First posted
- 2003-10-08
- Last updated
- 2025-02-03
Source: ClinicalTrials.gov record NCT00070590. Inclusion in this directory is not an endorsement.