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Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension Clinical research trials and Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension. Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension clinical trial. Test subjects typically receive the most expert healthcare available for their Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension  Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension
Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension
For Condition: Pulmonary Hypertension
Status: No longer recruiting
Sponsor(s): Myogen ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
LewisRubin, Principal Investigator, UCSD Medical Center
Baylor College of Medicine
Houston, Texas, 77030
United States
University of California San Diego Medical Center
San Diego, California, 92037
United States
Erasmus University
Brussels, ,
Belgium
Hannover Medical School
Hannover, , 30625
Germany
University of Bologna - Institute of Cardiology
Bologna, , 40136
Italy
Mayo Clinic
Rochester, Minnesota, 55905
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of California - San Francisco
San Francisco, California, 94143
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
New York Presbyterian Hospital
New York City, New York, 10032
United States
Rush Presbyterian
Chicago, Illinois, 60612
United States
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, 90502
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
Hopital Antoine Beclere
Clamart, Cedex, 92141
France
University of Colorado Health Sciences Center
Denver, Colorado, 80262
United States
Stanford University
Stanford, California, 94305
United States
University of Giessen
Giessen, , 35392
Germany
Ohio State University
Columbus, Ohio, 43210
United States
University of Southern California
Los Angeles, California, 90089
United States
St. Vincent's Hospital
Sidney, ,
Australia
Heart Care Associates
Milwaukee, Wisconsin, 53215
United States
Additional Information:
Study ID Numbers: AMB-220;
Study Start Date: September 2002
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046319
Other Pulmonary Hypertension Studies:
1. Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension
2. Natrecor in Pulmonary Hypertension
3. Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents with Infants at Risk of Sudden Death
4. Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension
5. Inhaled Nitric Oxide and Transfusion Therapy for Patients with Sickle Cell Anemia and Secondary Pulmonary Hypertension
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Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension
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