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Sponsors and Collaborators: |
FDA Office of Orphan Products Development United Therapeutics |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004497 |
OBJECTIVES:
I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Hypertension |
Drug: UT-15 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Study Start Date: | October 1998 |
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.
Ages Eligible for Study: | 8 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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:
Other:
--Patient Characteristics--
Cardiovascular:
Other:
United States, California | |
Los Angeles County Harbor-UCLA Medical Center | |
Torrance, California, United States, 90509 | |
United States, Illinois | |
Rush-Presbyterian-St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
University of Maryland Medical System | |
Baltimore, Maryland, United States, 21201 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Columbia University College of Physicians and Surgeons | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
United Therapeutics Corporation | |
Research Triangle Park, North Carolina, United States, 27709 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232-2516 |
Study Chair: | James Walker Crow | United Therapeutics |
Study ID Numbers: | 199/14287, UTC-FDR001545, UTC-P01-04 |
Study First Received: | October 18, 1999 |
Last Updated: | May 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00004497 |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases hypertensive disorder primary pulmonary hypertension rare disease |
Idiopathic pulmonary hypertension Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Respiration Disorders |
Treprostinil Vascular Diseases Rare Diseases Hypertension |
Cardiovascular Diseases |