Title of Study:
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Description:
This study is an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who are NOT currently receiving approved therapy for their PAH. Study visits will occur 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 include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies are 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 complete all assessments for 12 weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM – EXT).
Contact:
Kevin J Laliberte, PharmD 919-485-8350 x1207, klaliberte@unither.com
Website for more information and study sites
Study End Date:
October 2007
Study Sponsor:
United Therapeutics Corporation
