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

United Therapeutics

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: Placebo; Drug: UT-15C SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887978

TDE-PH-308

Details and patient eligibility

About

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).

Enrollment: 310 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• A subject is eligible for inclusion in this study if all of the following criteria apply:
• 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.
• Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
• Baseline six-minute walk distance (6MWD) between 150-425 meters
• Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
• Reliable and cooperative with protocol requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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310 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

UT-15C SR

Experimental group

Description:

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.

Treatment:

Drug: UT-15C SR