Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 354
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets. arm 2: Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.

Interventions: intervention 1: Oral treprostinil (UT-15C) sustained release tablets intervention 2: Placebo
Intervention descriptions: intervention 1: UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours intervention 2: Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours

Protocol document: