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NCT03043651 Clinical Trial

Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF

Pulmonary Hypertension Associated With HFpEF Clinical Trial

Official title:
An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03043651
Other study ID # TDE-HF-302
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 30, 2018
Est. completion date March 2, 2020

Study information
Verified date September 2020
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil was commercially available to treat PH associated with HFpEF or the study was discontinued by the Sponsor. 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.

Description:

Study TDE-HF-302 was a multicenter, open-label study in subjects participating and completing all required visits for Study TDE-HF-301. This study assessed the long-term safety of oral treprostinil in subjects with PH associated with HFpEF. 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.

Recruitment information / eligibility
Status Terminated
Enrollment 48
Est. completion date March 2, 2020
Est. primary completion date March 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. The subject participated in Study TDE-HF-301, remained on study drug, was compliant with study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of that study. Exclusion Criteria: 1. The subject was pregnant or lactating. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral treprostinil
Sustained-release oral tablets for TID administration

Locations
Country Name City State
United States Albany Medical College Albany New York
United States AnMed Health Pulmonary and Sleep Medicine Anderson South Carolina
United States VitaLink Research - Anderson Anderson South Carolina
United States Asheville Cardiology Associates Asheville North Carolina
United States Emory University Hospital Atlanta Georgia
United States Augusta University Augusta Georgia
United States Aurora Denver Cardiology Associates Aurora Colorado
United States University of Colorado Denver Aurora Colorado
United States Piedmont Physicians Georgia Lung Austell Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Bay Area Cardiology Associates Brandon Florida
United States St. Elizabeth's Medical Center Brighton Massachusetts
United States Montefiore Medical Center Bronx New York
United States Medical University of South Carolina Charleston South Carolina
United States St. Luke's Hospital Chesterfield Missouri
United States University of Illinois at Chicago Hospital Chicago Illinois
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 Baylor University Medical Center Dallas Texas
United States National Jewish Health Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Inova Heart and Vascular Institute Falls Church Virginia
United States Stern Cardiovascular Foundation Germantown Tennessee
United States Spectrum Health Medical Group Grand Rapids Michigan
United States Houston Methodist Research Institute Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States Community Heart and Vascular Hospital Indianapolis Indiana
United States Indiana University Health Methodist Research Institute, INC 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 Mayo Clinic - Jacksonville Jacksonville Florida
United States St. Vincent's Lung, Sleep, and Critical Care Specialists Jacksonville Florida
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Summit Medical Group Knoxville Tennessee
United States Lancaster General Hospital Lancaster Pennsylvania
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States University of Kentucky Medical Center Lexington Kentucky
United States South Denver Cardiology Littleton Colorado
United States Cedars-Sinai Medical Center Los Angeles California
United States University of California Los Angeles Pulmonary Division Los Angeles California
United States VA Healthcare System of Greater Los Angeles Los Angeles California
United States Kentuckiana Pulmonary Associates Louisville Kentucky
United States University of Louisville Physicians Outpatient Center Louisville Kentucky
United States Texas Tech University Health Sciences Center Lubbock Texas
United States WellStar Medical Group Marietta Georgia
United States Loyola University Medical Center Maywood Illinois
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States West Virginia University Hospital Morgantown West Virginia
United States Intermountain Medical Center Murray Utah
United States Vanderbilt University Medical Center Nashville Tennessee
United States Mount Sinai Medical Center New York New York
United States Barnabas Health Lung Center Newark New Jersey
United States Sentara Cardiovascular Research Institute Norfolk Virginia
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Central Florida Pulmonary Group, P.A. Orlando Florida
United States Florida Hospital Orlando Florida
United States OSF HealthCare Peoria Illinois
United States Banner University Medical Center Phoenix Phoenix Arizona
United States Pinehurst Medical Clinic Pinehurst North Carolina
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States The Oregon Clinic Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Carilion Clinic Roanoke Virginia
United States University of California - Davis Medical Center Sacramento California
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Chest Medicine Associates South Portland Maine
United States Providence Medical Research Center Spokane Washington
United States Pulmonary Health Physicians, PC Syracuse New York
United States University of South Florida ; Tampa General Hospital Tampa Florida
United States University of Toldedo Medical Center Toledo Ohio
United States University of Arizona Tucson Arizona
United States Medical Faculty Associates, George Washington University Washington District of Columbia
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Iowa Heart Center West Des Moines Iowa
United States Cleveland Clinic of Florida Weston Florida

Sponsors (1)
Lead Sponsor Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301 The primary objective of this study was to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The number of subjects with adverse events during the study is reported as the primary outcome measure, which was the only outcome measurement reported for this Sponsor-terminated study. Baseline through study completion, up to approximately 25 months