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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: BSF 208075 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Lewis Rubin, MD, Principal Investigator, Affiliation: UCSD Medical Center

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.

Clinical Details

Official title: A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline to Week 12 in six minute walk distance

Secondary outcome:

Change from baseline to Week 12 in:

Borg Dyspnea Index

WHO Functional Classification

Subject Global Assessment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

- -Disease Characteristics--

- Current diagnosis of either PPH or PAH secondary to the scleroderma spectrum of

disease (e. g., mixed connective tissue disease, systemic lupus erythematosus, systemic sclerosis, or overlap syndrome), anorexigen use, or human immunodeficiency virus (HIV) infection at the time of screening

- By means of a right heart catheterization, completed prior to Screening Visit

subjects must meet all of the following hemodynamic criteria:

- Mean pulmonary arterial pressure of >/= 25 mmHg

- Pulmonary vascular resistance >3 mmHg/L/min

- Pulmonary capillary wedge pressure or left ventricle end diastolic pressure of

<15 mmHg

- Stable on conventional therapy for PAH, including diuretics, digoxin, or supplemental

oxygen, for at least one month prior to the Screening Visit

- Subjects with a diagnosis of HIV must have stable disease status at the time of

screening. The subject may be enrolled if they meet the definition of a stable HIV status defined as:

- No addition of medications for treatment of HIV in the last two months

- No active opportunistic infection at the time of screening

- No hospitalizations due to HIV within the past four weeks

- Able to walk at least 150 meters, but no more than 450 meters, in a six minute walk

test at the time of the Screening Visit

- No pulmonary arterial hypertension due to or associated with congenital heart

disease, interstitial lung disease, chronic obstructive pulmonary disease, or chronic thrombotic and/or embolic disease, as documented by a historical echocardiogram, chest X-ray, ventilation/perfusion (V/Q) scan, and/or pulmonary arteriogram

- No subjects who have, as measured by a historical pulmonary function test:

- Total lung capacity (TLC) <70% of predicted normal or;

- Forced expiratory volume in one second (FEV1) <65% of predicted normal

- -Other Criteria--

- Subjects are excluded if they have:

- 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

Locations and Contacts

St. Vincent's Hospital, Sidney, Australia

Erasmus University, Brussels, Belgium

University of Giessen, Giessen 35392, Germany

Hannover Medical School, Hannover 30625, Germany

University of Bologna - Institute of Cardiology, Bologna 40136, Italy

University of Southern California, Los Angeles, California 90089, United States

University of California San Diego Medical Center, San Diego, California 92037, United States

University of California - San Francisco, San Francisco, California 94143, United States

Stanford University, Stanford, California 94305, United States

Los Angeles County Harbor-UCLA Medical Center, Torrance, California 90502, United States

Hopital Antoine Beclere, Clamart, Cedex 92141, France

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

Rush Presbyterian, Chicago, Illinois 60612, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

New York Presbyterian Hospital, New York, New York 10032, United States

Case Western Reserve University, Cleveland, Ohio 44106, United States

Ohio State University, Columbus, Ohio 43210, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Heart Care Associates, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: September 2002
Last updated: April 15, 2009

Page last updated: August 23, 2015

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