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Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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