Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
NCT ID: NCT00887978
Last Updated: 2013-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2009-06-30
2011-07-31
Brief Summary
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Patients who complete all assessments for 16-weeks will also be 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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Placebo
Identical placebo tablets to UT-15C, doses were titrated in the same manner
Placebo
UT-15C SR
Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
UT-15C SR
treprostinil diolamine sustained release tablets
Interventions
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UT-15C SR
treprostinil diolamine sustained release tablets
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 18 and 75 years of age, inclusive.
* Body weight at least 40 kg (approximately 90 lbs.)
* PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; 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.
* Baseline six-minute walk distance (6MWD) between 150-425 meters
* Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
* Reliable and cooperative with protocol requirements.
18 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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Lewis Rubin, MD
Role: STUDY_CHAIR
University of California, San Diego
Locations
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University of Alabama-Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialist, LTD
Phoenix, Arizona, United States
University of California, San Francisco-Fresno
Fresno, California, United States
UCSD Medical Center
La Jolla, 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-Jacksonville
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Chicago Hospitals
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Pulmonary Critical Care Medicine, Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Hospital
St Louis, Missouri, United States
University of 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 University 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
Lindner Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
The University of Toledo
Toledo, Ohio, United States
Legacy Pulmonary Northwest
Portland, Oregon, United States
OHSU
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UT Southwestern
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Inova Transplant Center
Falls Church, Virginia, United States
University Hospital Gasthuisberg
Leuven, , Belgium
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospitals
Edmonton, Alberta, Canada
Vancouver Coastal Health Respiratory Clinic
Vancouver, British Columbia, Canada
London Health Sciences Center
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Hospital Claude Huriez
Lille, Cedex, France
Hospital Haut Leveque
Pessac, Cedex, France
Hospital Cavale Blanche
Brest, , France
Universitaetsklinikum Dresden
Dresden, , Germany
University Hospital Greifswald
Greifswald, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Pulmonology Department Rambam Medical Center
Haifa, , Israel
Lady Davis Carmel Medical Centre
Haifa, , Israel
Pulmonary institute
Ramat Gan, , Israel
Azienda Ospedaliera Universitaria
Naples, , Italy
VUMC
Amsterdam, , Netherlands
Hospital de Santa Marta
Lisbon, , Portugal
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Lund University Hospital
Lund, , Sweden
Royal Free Hospital NHS Trust
London, , United Kingdom
Countries
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References
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Richter MJ, Schermuly R, Seeger W, Rao Y, Ghofrani HA, Gall H. Relevance of angiopoietin-2 and soluble P-selectin levels in patients with pulmonary arterial hypertension receiving combination therapy with oral treprostinil: a FREEDOM-C2 biomarker substudy. Pulm Circ. 2016 Dec;6(4):516-523. doi: 10.1086/688671.
Tapson VF, Jing ZC, Xu KF, Pan L, Feldman J, Kiely DG, Kotlyar E, McSwain CS, Laliberte K, Arneson C, Rubin LJ; FREEDOM-C2 Study Team. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013 Sep;144(3):952-958. doi: 10.1378/chest.12-2875.
Other Identifiers
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TDE-PH-308
Identifier Type: -
Identifier Source: org_study_id
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