Study:
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
Rationale:
n/a
Purpose:
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Pulmonary Fibrosis
Scleroderma, Systemic |
Drug: Bosentan |
Phase 2/Phase 3 |
Verified by
Actelion
February, 2010
Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov identifier: NCT00070590
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
The Cleveland Clinic
Cleveland, Ohio 44195
United States
n/a