Back to resultsOpen-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Primary Purpose
Pulmonary Hypertension Associated With HFpEF
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oral treprostinil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension Associated With HFpEF focused on measuring Pulmonary Hypertension, HFpEF, 6-Minute Walk Test, Oral Treprostinil
Eligibility Criteria
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:
- The subject was pregnant or lactating.
- The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
- 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.
Sites / Locations
- University of Alabama at Birmingham
- Banner University Medical Center Phoenix
- University of Arizona
- VA Healthcare System of Greater Los Angeles
- University of California Los Angeles Pulmonary Division
- Cedars-Sinai Medical Center
- University of California - Davis Medical Center
- Santa Barbara Cottage Hospital
- Aurora Denver Cardiology Associates
- University of Colorado Denver
- National Jewish Health
- South Denver Cardiology
- MedStar Georgetown University Hospital
- Medical Faculty Associates, George Washington University
- Bay Area Cardiology Associates
- Mayo Clinic - Jacksonville
- St. Vincent's Lung, Sleep, and Critical Care Specialists
- Central Florida Pulmonary Group, P.A.
- Florida Hospital
- University of South Florida ; Tampa General Hospital
- Cleveland Clinic of Florida
- Emory University Hospital
- Augusta University
- Piedmont Physicians Georgia Lung
- WellStar Medical Group
- University of Illinois at Chicago Hospital
- Loyola University Medical Center
- Advocate Christ Medical Center
- OSF HealthCare
- Indiana University Health Methodist Research Institute, INC
- Community Heart and Vascular Hospital
- Saint Vincent Hospital and Health Services
- University of Iowa Hospitals and Clinics
- Iowa Heart Center
- University of Kansas Medical Center
- University of Kentucky Medical Center
- Kentuckiana Pulmonary Associates
- University of Louisville Physicians Outpatient Center
- Chest Medicine Associates
- Tufts Medical Center
- Brigham and Women's Hospital
- St. Elizabeth's Medical Center
- Henry Ford Health System
- Spectrum Health Medical Group
- University of Minnesota
- St. Luke's Hospital
- Saint Luke's Hospital of Kansas City
- Dartmouth Hitchcock Medical Center
- Barnabas Health Lung Center
- Albany Medical College
- Montefiore Medical Center
- Mount Sinai Medical Center
- Pulmonary Health Physicians, PC
- Asheville Cardiology Associates
- Duke University Medical Center
- Pinehurst Medical Clinic
- The Lindner Research Center The Christ Hospital Health Network
- Cleveland Clinic
- The Ohio State University Wexner Medical Center
- University of Toldedo Medical Center
- The Oregon Clinic
- Lancaster General Hospital
- Allegheny General Hospital
- AnMed Health Pulmonary and Sleep Medicine
- VitaLink Research - Anderson
- Medical University of South Carolina
- Stern Cardiovascular Foundation
- Summit Medical Group
- Vanderbilt University Medical Center
- Baylor University Medical Center
- Houston Methodist Research Institute
- The University of Texas Health Science Center at Houston
- Texas Tech University Health Sciences Center
- Intermountain Medical Center
- Inova Heart and Vascular Institute
- Sentara Cardiovascular Research Institute
- Virginia Commonwealth University
- Carilion Clinic
- Providence Medical Research Center
- West Virginia University Hospital
- Aurora St. Luke's Medical Center
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral treprostinil
Arm Description
Sustained-release tablets for TID administration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03043651
First Posted
January 31, 2017
Last Updated
September 25, 2020
Sponsor
United Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT03043651
Brief Title
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated by Sponsor
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension Associated With HFpEF
Keywords
Pulmonary Hypertension, HFpEF, 6-Minute Walk Test, Oral Treprostinil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral treprostinil
Arm Type
Experimental
Arm Description
Sustained-release tablets for TID administration
Intervention Type
Drug
Intervention Name(s)
Oral treprostinil
Other Intervention Name(s)
Treprostinil diethanolamine, Treprostinil diolamine
Intervention Description
Sustained-release oral tablets for TID administration
Primary Outcome Measure Information:
Title
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301
Description
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.
Time Frame
Baseline through study completion, up to approximately 25 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
The subject was pregnant or lactating.
The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mardi Gomberg-Maitland, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Banner University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
VA Healthcare System of Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California Los Angeles Pulmonary Division
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of California - Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
South Denver Cardiology
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Medical Faculty Associates, George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Bay Area Cardiology Associates
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
St. Vincent's Lung, Sleep, and Critical Care Specialists
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
33204
Country
United States
Facility Name
Central Florida Pulmonary Group, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida ; Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Cleveland Clinic of Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Piedmont Physicians Georgia Lung
City
Austell
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
WellStar Medical Group
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Illinois at Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
OSF HealthCare
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Indiana University Health Methodist Research Institute, INC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Heart and Vascular Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Saint Vincent Hospital and Health Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
55242
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Physicians Outpatient Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Chest Medicine Associates
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health Medical Group
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Barnabas Health Lung Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pulmonary Health Physicians, PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13066
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pinehurst Medical Clinic
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
The Lindner Research Center The Christ Hospital Health Network
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Toldedo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
AnMed Health Pulmonary and Sleep Medicine
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
VitaLink Research - Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Summit Medical Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
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