NCT00325403

FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Oral treprostinil (UT-15C) Sustained Release Tablets	Sustained release oral tablet, twice daily
OTHER	Placebo	Placebo oral tablet twice daily

Timeline

• Start date: 2006-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2006-05-12
• Last updated: 2024-01-03
• Results posted: 2013-03-18

Locations

77 sites across 13 countries: United States, Austria, Belgium, Canada, China, France, India, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico