Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
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 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).