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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00070590 |
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.
Condition | Intervention | Phase |
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Pulmonary Fibrosis Scleroderma, Systemic |
Drug: Bosentan |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 132 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | September 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main inclusion criteria:
Main exclusion criteria:
Study ID Numbers: | AC-052-330, BUILD 2 |
Study First Received: | October 6, 2003 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00070590 |
Health Authority: | United States: Food and Drug Administration |
Scleroderma Fibrosing alveolitis Build bosentan |
Lung Diseases, Interstitial Skin Diseases Respiratory Tract Diseases Fibrosis Hamman-Rich syndrome Lung Diseases |
Connective Tissue Diseases Sclerosis Scleroderma, Systemic Fibrosing alveolitis Pulmonary Fibrosis Bosentan |
Pathologic Processes Therapeutic Uses Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |