NCT00887978

Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study 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: 310 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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. Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	UT-15C SR	treprostinil diolamine sustained release tablets
DRUG	Placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-04-24
• Last updated: 2013-01-15
• Results posted: 2013-01-15

Locations

62 sites across 12 countries: United States, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom