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Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension Clinical research trials and Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension. Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension clinical trial. Subjects typically recieve the finest healthcare available for their Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension  Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension
Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension
For Condition: Pulmonary Hypertension
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , United Therapeutics
Synopsis: OBJECTIVES: I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to center and etiology of disease. Patients receive conventional oral therapy plus a continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks. After completing 12 weeks of treatment, patients may continue therapy with open label UT-15. Patients who received placebo cross over to receive UT-15.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 8 Years/75 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of moderate to severe precapillary pulmonary hypertension (New York Heart Association class III/IV) unresponsive to attempted use of chronic oral vasodilators for at least 1 month Cardiac catheterization at baseline: Pulmonary artery pressure at least 25 mm Hg AND Pulmonary capillary wedge pressure or left ventricular end diastolic pressure no greater than 15 mm Hg AND Pulmonary vascular resistance greater than 3 mm Hg/L/min Echocardiogram at baseline: Right ventricular hypertrophy or dilation AND Normal left ventricular function AND Absence of mitral valve stenosis Chest radiograph within prior 3 months Clear lung fields OR Multiple patchy interstitial (not diffuse) lung fields AND At least 1 of the following: - Right ventricular enlargement - Prominence of main pulmonary artery - Enlarged hilar vessels - Decreased peripheral vessels No significant parenchymal lung disease within prior 3 months as evidenced by: Total lung capacity no greater than 70% predicted FEV/FVC ratio no greater than 50% Diffuse interstitial fibrosis or alveolitis by high resolution CT if total lung capacity is 70-80% or DLCO less than 60% No chronic thromboembolic disease with clot proximal to lobar bifurcation Baseline exercise capacity at least 50 meters walked in six minutes --Prior/Concurrent Therapy-- Endocrine therapy: - At least 30 days since prior chronic prostaglandin or prostaglandin analogue therapy (including Flolan IV) - No concurrent prostaglandins or prostaglandin analogues Other: - At least 1 month since prior new type of chronic therapy (e.g., different category of vasodilator, diuretic, digoxin) for pulmonary hypertension, except anticoagulants - At least 1 week since discontinuation of prior pulmonary hypertension medication, except anticoagulants - At least 30 days since prior participation in an investigational drug study - No other concurrent investigational drug - No concurrent chronic intravenous or inhaled medications (except oxygen) --Patient Characteristics-- Cardiovascular: - No portal hypertension - No left sided heart disease as defined by: Pulmonary capillary wedge pressure or left ventricular end diastolic pressure greater than 15 mm Hg OR LVEF less than 40% by MUGA or angiography OR LV shortening fraction less than 22% by echocardiography OR Symptomatic coronary disease (demonstrable ischemia) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Mentally and physically capable of using an infusion pump - HIV negative - No other disease associated with pulmonary hypertension (sickle cell anemia, schistosomiasis) - No musculoskeletal disorder (arthritis, artificial leg, etc.) or any disease limiting ambulation, or connected to a nonportable machine - No concurrent physiological condition contraindicating use of UT-15
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesCrow, Study Chair, United Therapeutics
University of Maryland Medical System *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Lewis Rubin 410-328-7516
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Michael McGoon 507-284-3903
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Stuart Rich 312-942-5000
Columbia University College of Physicians and Surgeons *Recruiting*
New York City, New York, 10032
United States
Recruiting Robyn Barst 212-305-2500
United Therapeutics Corporation *Recruiting*
Research Triangle Park, North Carolina, 27709
United States
Recruiting James Crow 919-485-8350
Los Angeles County Harbor-UCLA Medical Center *Recruiting*
Torrance, California, 90509
United States
Recruiting Ronald Oudiz 310-222-3560
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting James Loyd 615-322-5000
Additional Information:
Study ID Numbers: 199/14287; UTC-FDR001545,UTC-P01-04
Study Start Date: October 1998
Record last reviewed: September 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004497
Other Pulmonary Hypertension Studies:
1. Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents with Infants at Risk of Sudden Death
2. Study of BSF 208075 evaluating exercise capacity in patients with pulmonary arterial hypertension
3. Natrecor in Pulmonary Hypertension
4. Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
5. Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
Related Studies:
Other Pulmonary Hypertension Clinical Trials
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Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension
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