FREEDOM - M: Oral Treprostinil as Monotherapy 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, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Key facts

Study ID

NCT00325403

Run by

United Therapeutics

People needed

349

Starts

2006-10-01

Expected to finish

2011-04-01

Last updated by the study team

2024-01-03

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 12 and 75 years of age, inclusive.
• Body weight at least 40 kg with a Body Mass Index < 45
• PAH that is either idiopathic/heritable; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.
• Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
• Baseline 6-minute walk distance between 200 and 425 meters, inclusive.
• Reliable and cooperative with protocol requirements.

You may not qualify if…

• Nursing or pregnant.
• Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or prostacyclin within 30 days of Baseline.
• 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
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• University of California, San Francisco-Fresno — Fresno, California, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• University of Colorado Health Science Center — Aurora, Colorado, United States
• University of Florida - Shands Hospital — Jacksonville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Alexandria Cardiology Clinic — Alexandria, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University Hospital — St Louis, Missouri, United States
• Nebraska Medical Center — Omaha, Nebraska, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• University of Alabama-Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.