Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 349
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Subjects receive UT-15C (oral treprostinil) twice daily. arm 2: Subjects receive placebo (sugar pill) twice daily.

Interventions: intervention 1: Oral treprostinil (UT-15C) Sustained Release Tablets intervention 2: Placebo
Intervention descriptions: intervention 1: Sustained release oral tablet, twice daily intervention 2: Placebo oral tablet twice daily

Protocol document: