A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension

TDE-PH-302

This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

2006-10-01

2011-04-01

2011-04-01

Completed

Early phase I

349

Inclusion Criteria: * Between 12 and 75 years of age, inclusive. * Body weight at least 40 kg with a Body Mass Index \< 45 * PAH that is either idiopathic/heritable; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV. * Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH. * Baseline 6-minute walk distance between 200 and 425 meters, inclusive. * Reliable and cooperative with protocol requirements. Exclusion Criteria: * Nursing or pregnant. * Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or prostacyclin within 30 days of Baseline. * PAH due to conditions other than noted in the above inclusion criteria. * History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease. * Use of an investigational drug within 30 days of Baseline.

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2024-01-03