Study of BSF 208075 Evaluating Exercise Capacity in Patients With Pulmonary Arterial Hypertension

Phase 2

Completed

Brief Summary: The purpose of this study is to determine if treating patients suffering from moderate to severe pulmonary arterial hypertension with BSF 208075 will improve the patients' ability to exercise.

Detailed Description: This is a randomized, double-blind study evaluating the effectiveness of BSF 208075 in treating patients with moderate to severe pulmonary hypertension. A four-week Screening Period will be followed by 12 weeks of Treatment. After a subject qualifies for the study, the subject will be randomized to one of four doses of BSF 208075 (1.0, 2.5, 5.0 or 10.0 mg po qd). Subjects randomized to the 1.0 or 2.5 mg dose groups will receive their respective doses of BSF 208075 each day throughout the 12-week Treatment Period. Subjects in the two other dose groups will begin treatment at 2.5 mg per day for two weeks and then their dose will be increased to 5.0 mg for an additional two weeks. After two weeks of treatment at 5.0 mg, subjects randomized to the 10.0 mg dose group will undergo a final up-titration. After reaching the randomized dose level, subjects will receive their assigned dose throughout the Treatment Period. Subjects will remain on the randomized treatment through Week 12. In the event that a subject is not tolerating study drug, dose adjustment is permitted during the Treatment Period. Upon completion of the 12-week Treatment Period subjects will either complete a four-week Down-titration Period or enter an optional 12-week Open-label Extension. All subjects that choose to participate in the Open-label Extension will be unblinded and have their dose of BSF 208075 optimized based on the subjects response during the Treatment Period.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 12 in six minute walk distance

Secondary Outcome Measures

Name	Time	Method
WHO Functional Classification
Subject Global Assessment
Change from baseline to Week 12 in:
Borg Dyspnea Index

Locations (21): University of California San Diego Medical Center
🇺🇸
San Diego, California, United States
Los Angeles County Harbor-UCLA Medical Center
🇺🇸
Torrance, California, United States
Rush Presbyterian
🇺🇸
Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Heart Care Associates
🇺🇸
Milwaukee, Wisconsin, United States
Hopital Antoine Beclere
🇫🇷
Clamart, Cedex, France
University of Bologna - Institute of Cardiology
🇮🇹
Bologna, Italy
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
University of Colorado Health Sciences Center
🇺🇸
Denver, Colorado, United States
New York Presbyterian Hospital
🇺🇸
New York, New York, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Erasmus University
🇧🇪
Brussels, Belgium
St. Vincent's Hospital
🇦🇺
Sidney, Australia
University of California - San Francisco
🇺🇸
San Francisco, California, United States
Stanford University
🇺🇸
Stanford, California, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
University of Giessen
🇩🇪
Giessen, Germany
Hannover Medical School
🇩🇪
Hannover, Germany