Study:
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
Rationale:
n/a
Purpose:
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).
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Pulmonary Hypertension |
Drug: UT-15C SR
Drug: Placebo |
Phase 3 |
Verified by
United Therapeutics
December, 2012
Sponsored by: United Therapeutics
Information provided by: United Therapeutics
ClinicalTrials.gov identifier: NCT00887978
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cleveland Clinic Florida
Weston, Florida 33331
United States
Lewis Rubin, MD., Study Chair