Pulmonary Hypertension Clinical Trial
Official title:
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
This study was an international, multi-center, randomized, double-blind, placebo-controlled
study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e.,
endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred
at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test.
Study procedures included routine blood tests, medical history, physical exams, disease
evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select
centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.
Patients who completed all assessments for 16-weeks were also eligible to enter an
open-label, extension phase study (FREEDOM - EXT).
n/a
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