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

Study:

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

Rationale:

n/a

Purpose:

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).

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Pulmonary Hypertension Drug: UT-15C SR
Drug: Placebo
Phase 3

Verified by United Therapeutics December, 2012

Sponsored by: United Therapeutics
Information provided by: United Therapeutics
ClinicalTrials.gov identifier: NCT00887978

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Cleveland Clinic Florida
Weston, Florida 33331
United States

Lewis Rubin, MD., Study Chair

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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