Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension
I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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.
|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|
|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|