|
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension Clinical research trials and Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension. Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension  Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
For Condition: Pulmonary Hypertension
Status: No longer recruiting
Sponsor(s): ICOS-Texas Biotechnology , ICOS,Texas Biotechnology Corporation
Synopsis: This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1.) NYHA Class II, III or IV 2.) 16 to 75 years of age 3.) Specific peak VO2 range 4.) PPH, PAH due to connective tissue disease or select congenital heart disease 5.) Qualifying cardiac catheterization 6.) History of CXR and qualifying pulmonary function test 7.) History of qualifying ventilation-perfusion lung scan 8.) History of qualifying echocardiogram 9.) Women of childbearing potential must use contraceptives 10.) Stable dose of corticosteroids if prescribed Exclusion Criteria: 1.) Significant lung disease 2.) Chronic liver disease 3.) Uncontrolled sleep apnea 4.) History of specific types of left heart disease 5.) Any disorder that compromises ability to give informed consent 6.) Uncontrolled sleep apnea 7.) Inability to perform bicycle exercise test 8.) On-going treatment with an experimental drug or device within the last 30 days 9.) HIV infection 10.) Specific liver dysfunction 11.) Chronic renal disease 12.) Pregnancy/Nursing 13.) Chronic active hepatitis B or C 14.) Chronic Flolan or Tracleer use within the last 30 days
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
LynFrumkin, Study Director, ICOS
Dekalb Medical Center
Decatur, Georgia, 30033
United States
Harbor-UCLA Medical Center
Torrance, California, 90502
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Colorado/ Health Science Center
Denver, Colorado, 80262
United States
Maine Medical Center
Portland, Maine, 04102
United States
Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Mayo Clinic - Division of Cardiovascular Disease
Rochester, Minnesota, 55905
United States
Division of Cardiology - The Ohio State University Medical Center
Columbus, Ohio, 43210
United States
Baylor College of Medicine Pulmonary & Critical Care Section
Houston, Texas, 77030
United States
The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care
Cleveland, Ohio, 44195
United States
University of Pittsburgh Medical Center, CHF/Transplantation Cardiology
Pittsburgh, Pennsylvania, 15213
United States
Medical College of Georgia
Augusta, Georgia, 30912
United States
John Hopkins Hospital
Baltimore, Maryland, 21287
United States
LSU - School of Medicine
New Orleans, Louisiana, 70112
United States
Columbia Presbyterian Medical Center
New York City, New York, 10032
United States
Oregon Health Sciences
Portland, Oregon, 97201
United States
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2
Canada
University of Michigan Hospital, Division of Cardiology
Ann Arbor, Michigan, 48109
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Emory University Hospital - McKelvey Lung Transplantation Center
Atlanta, Georgia, 30322
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Pulmonary Division - Rhode Island Hospital
Providence, Rhode Island, 02903
United States
The Children's Hospital
Denver, Colorado, 80218
United States
University of Wisconsin Medical School
Milwaukee, Wisconsin, 53215
United States
University of Southern California Hospital, Ambulatory Health Sciences
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: FPH01/FPH01-X;
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034307
Other Pulmonary Hypertension Studies:
1. Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
2. Inhaled Nitric Oxide and Transfusion Therapy for Patients with Sickle Cell Anemia and Secondary Pulmonary Hypertension
3. Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
4. Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents with Infants at Risk of Sudden Death
5. Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension
Related Studies:
Other Pulmonary Hypertension Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
|
|
|
|
|
|
|
|
