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

NCT ID: NCT00046319

Last Updated: 2009-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2003-06-30

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

BSF 208075

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• A serum ALT or AST lab value that is greater than 1.5 times the upper limit of normal at any time during the Screening Period
• Contraindication to treatment with an endothelin receptor antagonist
• Demonstrated noncompliance with previous medical regimens
• A recent history of abusing alcohol or illicit drugs
• Participated in a clinical study involving another investigational drug or device within four weeks before the Screening Visit or at any time during the study

--Patient Characteristics--

• Women of childbearing potential must:

• Have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit. Women who are surgically sterile or those who are post-menopausal for at least two years are not considered to be of childbearing potential
• Agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit
• All males must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the Informed Consent Form

Excluded:

• Pregnant or breastfeeding
• Have a history of malignancies within the past five years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix
• Any other disease which, in the investigators opinion, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject

--Prior/Concurrent Therapy--

• Stable on conventional therapy for PAH, including diuretics, digoxin, or supplemental oxygen, for at least one month prior to the Screening Visit

Excluded Therapies:

• IV inotropes within two weeks prior to the Screening Visit
• Chronic prostanoid therapy (epoprostenol, treprostinil, iloprost, beraprost, or any other investigational prostacyclin derivative) within four weeks prior to the Screening Visit
• Bosentan within four weeks prior to the Screening Visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Principal Investigators

Lewis Rubin, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Medical Center

Locations

University of Southern California

Los Angeles, California, United States

University of California San Diego Medical Center

San Diego, California, United States

University of California - San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

Los Angeles County Harbor-UCLA Medical Center

Torrance, California, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Rush Presbyterian

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

New York Presbyterian Hospital

New York, New York, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Heart Care Associates

Milwaukee, Wisconsin, United States

St. Vincent's Hospital

Sydney, , Australia

Erasmus University

Brussels, , Belgium

Hopital Antoine Beclere

Clamart, Cedex, France

University of Giessen

Giessen, , Germany

Hannover Medical School

Hanover, , Germany

University of Bologna - Institute of Cardiology

Bologna, , Italy

Countries

United States; Australia; Belgium; France; Germany; Italy

Other Identifiers

AMB-220

Identifier Type: -

Identifier Source: org_study_id