NCT00325442

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)

A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-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	UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
DRUG	Placebo	Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-09-01
• Completion: 2010-12-01
• First posted: 2006-05-12
• Last updated: 2017-08-02
• Results posted: 2013-06-10

Locations

72 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Poland, Spain, United Kingdom