Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2008 |
| End Date: | May 2010 |
Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed
protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability
of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability
of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
Inclusion Criteria:
Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of
study (EOS) visit.
- Signed informed consent prior to initiation of any study-related procedures.
- Women of childbearing potential must have a negative serum pregnancy test and use
reliable methods of contraception during study treatment and for 3 months after study
treatment termination.
Exclusion Criteria:
- Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).
- Pregnancy or breast-feeding.
- AST and/or ALT > 3 times the upper limit of the normal range.
- Any known factor or disease that might interfere with treatment compliance, study
conduct or interpretation of the results, such as drug or alcohol dependence or
psychiatric disease.
- Known hypersensitivity to bosentan or any of the excipients.
We found this trial at
23
sites
Darlinghurst, New South Wales 2010
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Utah Research is a major component in the life of the U benefiting...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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