Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension
- Conditions
- Pulmonary Hypertension
- Registration Number
- NCT00004497
- Lead Sponsor
- United Therapeutics
- Brief Summary
OBJECTIVES:
I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.
- Detailed Description
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.
Completion date provided represents the completion date of the grant per OOPD records
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Los Angeles County Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland Medical System
🇺🇸Baltimore, Maryland, United States
Columbia University College of Physicians and Surgeons
🇺🇸New York, New York, United States
United Therapeutics Corporation
🇺🇸Research Triangle Park, North Carolina, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States