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Sponsored by: |
Actelion |
Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00082186 |
The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).
Condition | Intervention | Phase |
Hypertension, Pulmonary |
Drug: bosentan |
Phase IV |
Genetics Home Reference related topics: | pulmonary arterial hypertension |
MedlinePlus related topics: | High Blood Pressure Pulmonary Hypertension |
ChemIDplus related topics: | Bosentan |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | TRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-Label, Single-Arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial Hypertension |
Enrollment: | 22 |
Study Start Date: | October 2002 |
Study Completion Date: | November 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Oral bosentan tablets
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Drug: bosentan
Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |||||
University of Alabama-Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, California | |||||
University of California at San Diego | |||||
La Jolla, California, United States, 92037-1300 | |||||
Harbor - UCLA Medical Center | |||||
Torrance, California, United States, 90502 | |||||
United States, Colorado | |||||
University of Colorado Health Sciences Center | |||||
Denver, Colorado, United States, 80262 | |||||
United States, New York | |||||
New York Presbyterian Hospital | |||||
New York, New York, United States, 10032-3784 | |||||
United States, Texas | |||||
Baylor College of Medicine | |||||
Houston, Texas, United States, 77030 | |||||
Australia | |||||
Royal Perth Hospital | |||||
Perth, Australia, 6000 | |||||
St. Vincent's Hospital | |||||
Darlinghurst, Australia, 2010 | |||||
Brazil | |||||
University of Sao Paulo | |||||
Sao Paulo, Brazil | |||||
Federal University of Sao Paulo | |||||
Sao Paulo, Brazil | |||||
Czech Republic | |||||
1st Internal Cardiology Clinic | |||||
Brno, Czech Republic | |||||
The Center for Congenital Heart Disease in Adults | |||||
Prague, Czech Republic | |||||
Hungary | |||||
National Koranyi Institute of Pulmonology | |||||
Budapest, Hungary, 1529 |
Actelion |
Study Director: | Andrea Lauer, Ph.D. | Actelion Pharmaceuticals US, Inc. |
Study Director: | Maurizio Rainisio, Ph.D. | Actelion |
Study Director: | Frederic Bodin, M.D. | Actelion |
Tracleer approval page at Drugs@FDA.gov 
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Responsible Party: | Actelion ( Andrea Lauer, PhD ) |
Study ID Numbers: | AC-052-402 |
First Received: | April 30, 2004 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00082186 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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