Title of Study:
FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Description:
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks 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. One optional substudy is also a part of FREEDOM-C at select centers – a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.
Patients who complete all assessments for 16-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
