Status:
COMPLETED
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin recep...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A subject is eligible for inclusion in this study if all of the following criteria apply:
- Between 18 and 75 years of age, inclusive.
- Body weight at least 40 kg (approximately 90 lbs.)
- PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; associated with HIV.
- Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
- Baseline six-minute walk distance (6MWD) between 150-425 meters
- Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
- Reliable and cooperative with protocol requirements.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00887978
Start Date
June 1 2009
End Date
July 1 2011
Last Update
January 15 2013
Active Locations (62)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Arizona Pulmonary Specialist, LTD
Phoenix, Arizona, United States, 85013
3
University of California, San Francisco-Fresno
Fresno, California, United States, 93701
4
UCSD Medical Center
La Jolla, California, United States, 92037