United Therapeutics Corporation Completes Enrollment of FREEDOM-C(2) Trial
FREEDOM-C(2) is a 16-week, multi-center, international, double-blind, randomized, placebo-controlled study of a sustained release oral formulation of treprostinil diethanolamine (UT-15C) in pulmonary arterial hypertension (PAH) patients receiving an endothelin receptor antagonist and/or a phosphodiesterase-5 inhibitor.
The FREEDOM-C(2) study randomized 313 patients, compared to a target enrollment of 300 patients. The primary endpoint of the trial is change in six-minute walk distance at Week 16 in the treatment group compared to placebo.
"Completion of enrollment in FREEDOM-C(2) represents another significant milestone toward the planned filing of the UT-15C NDA," said
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Forward-looking Statements
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, our expectations on the timing of unblinding of the FREEDOM-C(2) study, our belief that the FREEDOM-C(2) study unblinding will bring us closer to the goal of achieving an approved oral prostacyclin therapy for PAH and our expectations that the study will enhance early adoption and market uptake of UT-15C. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the
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