FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 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. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals. Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

Key facts

Study ID

NCT00760916

Run by

United Therapeutics

People needed

0

Starts

2008-12-01

Expected to finish

2009-01-01

Last updated by the study team

2013-01-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18 and 70 years of age, inclusive
• Body weight at least 50 kilograms
• PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; 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 or not currently receiving approved PAH therapy.
• Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
• Reliable and cooperative with protocol requirements.

You may not qualify if…

• Nursing or pregnant.
• Received a prostacyclin within the past 30 days.
• PAH due to conditions other than noted in the above inclusion criteria.
• History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
• Use of an investigational drug within 30 days of Baseline

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Stanford University — Stanford, California, United States
• Pulmonary Hypertension Clinic — Aurora, Colorado, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Maine Medical Center — Portland, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University Hospital — St Louis, Missouri, United States
• Weill Cornell Medical Center — New York, New York, United States
• Columbia Presbyterian Medical Center — New York, New York, United States
• Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Lagacy Clinic Northwest — Portland, Oregon, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

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