Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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 receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Key facts

Study ID

NCT00887978

Run by

United Therapeutics

People needed

310

Starts

2009-06-01

Expected to finish

2011-07-01

Last updated by the study team

2013-01-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Arizona Pulmonary Specialist, LTD — Phoenix, Arizona, United States
• University of California, San Francisco-Fresno — Fresno, California, United States
• UCSD Medical Center — La Jolla, California, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• University of Colorado Health Science Center — Aurora, Colorado, United States
• University of Florida-Jacksonville — Jacksonville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Pulmonary Critical Care Medicine, Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• Columbia University Presbyterian Medical Center — New York, New York, United States
• Mary M Parkes Center for Asthma, Allergy and Pulmonary Care — Rochester, New York, United States
• University of Alabama-Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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