Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
NCT ID: NCT03043651
Last Updated: 2020-10-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
48 participants
INTERVENTIONAL
2018-01-30
2020-03-02
Brief Summary
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The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March 2020. Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed.
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Detailed Description
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Subjects received oral treprostinil as 0.125-, 0.25-, 1-, and 2.5-mg sustained-release tablets. For subjects who were randomly allocated to receive oral treprostinil in Study TDE-HF-301, the initial dose of oral treprostinil was the same as the final dose in Study TDE-HF-301. Subjects randomly allocated to receive placebo in Study TDE-HF-301 were administered the initial dose of oral treprostinil at 0.125 mg 3 times daily (TID). Dose increases could occur in 0.125-mg increments every 72 hours at the discretion of the Investigator up to 6 mg TID, the maximum allowable dose determined by the Data Monitoring Committee during Study TDE-HF-301. Doses of study drug were to be increased in the absence of dose-limiting drug-related adverse events (AEs) to ensure that each subject received the optimal dose throughout the study. Subjects returned for visits at Weeks 6, 12, 18, and 24, and every 12 weeks thereafter. Subjects who terminated the study early were asked to return to the study center for a final evaluation.
Safety assessments consisted of AEs, clinical laboratory parameters, and clinical assessment of heart failure signs and symptoms.
Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oral treprostinil
Sustained-release tablets for TID administration
Oral treprostinil
Sustained-release oral tablets for TID administration
Interventions
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Oral treprostinil
Sustained-release oral tablets for TID administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
3. The subject developed a concurrent illness or condition during Study TDE-HF-301, which, in the opinion of the Investigator, represented a risk to the subject's overall health if they enrolled in this study.
18 Years
85 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Mardi Gomberg-Maitland, MD
Role: PRINCIPAL_INVESTIGATOR
George Washington University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
VA Healthcare System of Greater Los Angeles
Los Angeles, California, United States
University of California Los Angeles Pulmonary Division
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
University of Colorado Denver
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
South Denver Cardiology
Littleton, Colorado, United States
Cleveland Clinic of Florida
Weston, Florida, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Medical Faculty Associates, George Washington University
Washington D.C., District of Columbia, United States
Bay Area Cardiology Associates
Brandon, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Florida Hospital
Orlando, Florida, United States
University of South Florida ; Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Piedmont Physicians Georgia Lung
Austell, Georgia, United States
WellStar Medical Group
Marietta, Georgia, United States
University of Illinois at Chicago Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
OSF HealthCare
Peoria, Illinois, United States
Indiana University Health Methodist Research Institute, INC
Indianapolis, Indiana, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Iowa Heart Center
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, United States
Chest Medicine Associates
South Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Luke's Hospital
Chesterfield, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Barnabas Health Lung Center
Newark, New Jersey, United States
Albany Medical College
Albany, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Pulmonary Health Physicians, PC
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States
The Lindner Research Center The Christ Hospital Health Network
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Toldedo Medical Center
Toledo, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, United States
VitaLink Research - Anderson
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Summit Medical Group
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
Providence Medical Research Center
Spokane, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TDE-HF-302
Identifier Type: -
Identifier Source: org_study_id
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