FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Completed · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Hypertension
In brief
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Key facts
- Study ID
- NCT00325442
- Run by
- United Therapeutics
- People needed
- 354
- Starts
- 2006-10-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2017-08-02
Who can join
Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Between 12 and 70 years of age, inclusive.
- Body weight at least 45 kg (approximately 100 pounds).
- PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV.
- Baseline 6-minute walk distance between 150 and 450 meters, inclusive.
- 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.
- 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
- Arizona Pulmonary Specialist — Phoenix, Arizona, United States
- University of Arizona Health Science Center — Tucson, Arizona, United States
- West Los Angeles VA Healthcare Center — Los Angeles, California, United States
- Stanford University, Pulmonary and Critical Care — Palo Alto, California, United States
- UC Davis Medical Center — Sacramento, California, United States
- University of California-San Francisco — San Francisco, California, United States
- Harbour-UCLA Medical Center — Torrance, California, United States
- The Children's Hospital — Aurora, Colorado, United States
- Pulmonary Hypertension Clinic — Aurora, Colorado, United States
- University of Chicago — Chicago, Illinois, United States
- University of Iowa Health Care — Iowa City, Iowa, United States
- Maine Medical Center — Portland, Maine, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- John's Hopkins Hospital — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University Hospital — St Louis, Missouri, United States
- Columbia Presbyterian Medical Center — New York, New York, United States
- Mary M Parkes Center for Asthma, Allergy and Pulmonary Care — Rochester, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University Hospitals of Cleveland — Cleveland, Ohio, United States
- University of Alabama-Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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