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

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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).


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
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34800 Bob Wilson Drive
San Diego, California 92103
1065
mi
from 98109
San Diego, CA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
2178
mi
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Atlanta, GA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
1737
mi
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Chicago, IL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
1890
mi
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Houston, TX
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
703
mi
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Salt Lake City, UT
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Birmingham, Alabama 35294
2079
mi
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Birmingham, AL
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Boston, Massachusetts 02215
2485
mi
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Boston, MA
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2291 Westwood Northern Boulevard
Cincinnati, Ohio 45267
1963
mi
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Cincinnati, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
2016
mi
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Cleveland, OH
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1680
mi
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Dallas, TX
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7748
mi
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Darlinghurst,
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1022
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Denver, CO
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Falls Church, Virginia 22042
2316
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Falls Church, VA
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Los Angeles, California 90095
958
mi
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Los Angeles, CA
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Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
1616
mi
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Madison, WI
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Nashville, Tennessee 37232
1970
mi
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Nashville, TN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
2432
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New Haven, CT
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2373
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Philadelphia, PA
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San Francisco, California 94143
681
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San Francisco, CA
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Scottsdale, Arizona 85259
1114
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Scottsdale, AZ
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
2
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Seattle, WA
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705
mi
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Stanford, CA
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Wichita, Kansas 67208
1437
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Wichita, KS
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