FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
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).