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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




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


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 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


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