Open-label Study With Bosentan in Interstitial Lung Disease (BUILD 2 OL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00319033|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Lung Disease Scleroderma||Drug: bosentan||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||February 2006|
U.S. FDA Resources
- Change from baseline to all assessed time points in 6-minute walk test distance.
- Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value).
- Transition Dyspnea Index at all assessed time points.
- Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 ≥ 4%), trough SpO2 and area under the curve during 6-minute walk test.
- Adverse events; serious adverse events.
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): NCT00319033
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