Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
(FREEDOM-C2 Trial)

Recruiting in Palo Alto (17 mi)

+61 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: United Therapeutics

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Lewis Rubin, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

Between 18 and 75 years of age, inclusive.

Body weight at least 40 kg (approximately 90 lbs.)

PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; associated with HIV.

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Treatment Details

Interventions

Placebo (Drug)
UT-15C SR (Other)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: UT-15C SRExperimental Treatment1 Intervention

Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.

Group II: PlaceboPlacebo Group1 Intervention

Identical placebo tablets to UT-15C, doses were titrated in the same manner