FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT00325403
Last Updated: 2024-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
349 participants
INTERVENTIONAL
2006-10-31
2011-04-30
Brief Summary
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Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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UT-15C (oral treprositnil)
Subjects receive UT-15C (oral treprostinil) twice daily.
Oral treprostinil (UT-15C) Sustained Release Tablets
Sustained release oral tablet, twice daily
Placebo
Subjects receive placebo (sugar pill) twice daily.
Placebo
Placebo oral tablet twice daily
Interventions
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Oral treprostinil (UT-15C) Sustained Release Tablets
Sustained release oral tablet, twice daily
Placebo
Placebo oral tablet twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or prostacyclin within 30 days of Baseline.
12 Years
75 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Laliberte, PharmD
Role: STUDY_DIRECTOR
United Therapeutics
Locations
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University of Alabama-Birmingham
Birmingham, Alabama, United States
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
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
The Lindner Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Legacy Clinic Northwest
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine, Pulmonary & Critical Care
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Heart Care Associates
Milwaukee, Wisconsin, United States
Universitaet Wien
Vienna, , Austria
Hospital Erasme
Brussels, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Peter Lougheed Centre
Calgary, Alberta, Canada
London Health Science Centre
London, Ontario, Canada
SMBD Jewish General Hospital
Montreal, Quebec, Canada
Beijing Shijitan Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Hospital Antoine Beclere
Clamart, , France
PRIME Hospitals
Hyderbad, Andhra Pradesh, India
Care Institute of Medical Science
Ahmedabad, Gujarat, India
Lifecare Institute of Medical Sciences & Research
Ahmedabad, Gujarat, India
Narayana Hrudayalaya Institute of Medical Sciences
Bangalore, Karnataka, India
Asian Heart Institute and Research Centre
Parel Mumbai, Maharashtra, India
Poona Hospital and Research Centre
Pune, Maharashtra, India
Sri Ramachandra Medical College
Chennai, Tamil Nadu, India
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, India
K. S. Hospital
Chennai, Tamil Nadu, , India
Sir Ganga Ram Hospital
New Delhi, , India
Ruby Hall Clinic
Pune, , India
Care Hospital
Visakhapatnam, Andra Pradesh, , India
Hadassah Ein-Kerem Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Hashomer Medical Center
Ramat Gan, , Israel
Universita degli Studi Bologna
Bologna, , Italy
Instituto Nacional de Cardiologia
Mexico City, Mexico City, Mexico
Hospital Universitario UANL
Monterrey, Nuevo León, Mexico
Unidad de Investigacion Clinica en Medicina (UDICEM)
Monterrey, , Mexico
VU Medisch Centrum (VUCM)
Amsterdam, , Netherlands
Krakowski Szpital Specjalistyczny im. (Kraków Specialist Hospital)
Krakow, , Poland
National Tuberculosis and Lung Disease Research Institute
Warsaw, , Poland
Wojewódzki Szpital Specjalistyczny we Wroclawiu (Provincial Specialist Hospital in Wrocław)
Wroclaw, , Poland
Auxilio Mutuo Hospital
Guaynabo, , Puerto Rico
Countries
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References
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Jing ZC, Parikh K, Pulido T, Jerjes-Sanchez C, White RJ, Allen R, Torbicki A, Xu KF, Yehle D, Laliberte K, Arneson C, Rubin LJ. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013 Feb 5;127(5):624-33. doi: 10.1161/CIRCULATIONAHA.112.124388. Epub 2013 Jan 10.
Related Links
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FREEDOM Studies Website
Other Identifiers
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TDE-PH-302
Identifier Type: -
Identifier Source: org_study_id
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