Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
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|ClinicalTrials.gov Identifier: NCT00070590|
Recruitment Status : Completed
First Posted : October 8, 2003
Last Update Posted : February 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Fibrosis Scleroderma, Systemic||Drug: Bosentan||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||September 2005|
- Change from baseline to End-of-Study in 6-minute walk distance.
- Time to death (all causes) or to worsening of PFTs up to End-of-Study.
- Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline ≥ 10% in FVC OR decrease from baseline ≥ 15% in DLco AND ≥ 6% in FVC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070590