A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension Receiving UT-15C in Combination with a PDE5-I

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Investigator: Vijay P. Balasubramanian, MD, MRCP
Sponsor: United Therapeutics Corporation

Location(s): China; South Korea; France; Italy; Mexico

Description

This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving PDE-5 inhibitor or ERA for at least 30 days but not more than one year prior to randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311).