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Phase III Randomized Study of UT-15 in Patients with Primary Pulmonary Hypertension
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development United Therapeutics
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
OBJECTIVES: I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.
Condition | Treatment or Intervention | Phase |
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Pulmonary Hypertension |
Drug: UT-15 |
Phase III |
MedlinePlus related topics: Pulmonary Hypertension
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Study start: 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.
Eligibility
Ages Eligible for Study: 8 Years - 75 Years, Genders Eligible for Study: Both
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:
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:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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