Pulmonary Hypertension Associated With HFpEFPhase 3NCT03043651
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
A Phase 3 study testing Oral treprostinil in people with Pulmonary Hypertension Associated With HFpEF, run by United Therapeutics at 82 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension Associated With HFpEF
- What is being tested?
- Oral treprostinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 82 sitesUnited States
- Study dates
- 30 Jan 2018to 2 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
82 sites in 1 country.
82 sites in 1 country
United States82 sites
Albany Medical College
Albany, New York, 12208
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621
VitaLink Research - Anderson
Anderson, South Carolina, 29621
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Emory University Hospital
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30912
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
University of Colorado Denver
Aurora, Colorado, 80045
Piedmont Physicians Georgia Lung
Austell, Georgia, 30309
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Bay Area Cardiology Associates
Brandon, Florida, 33511
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Medical University of South Carolina
Charleston, South Carolina, 29425
St. Luke's Hospital
Chesterfield, Missouri, 63017
University of Illinois at Chicago Hospital
Chicago, Illinois, 60612
The Lindner Research Center The Christ Hospital Health Network
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas, 75246
National Jewish Health
Denver, Colorado, 80206
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503
Houston Methodist Research Institute
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University Health Methodist Research Institute, INC
Indianapolis, Indiana, 46202
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 55242
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, 33204
University of Kansas Medical Center
Kansas City, Kansas, 66160
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Summit Medical Group
Knoxville, Tennessee, 37909
Lancaster General Hospital
Lancaster, Pennsylvania, 17601
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Medical Center
Lexington, Kentucky, 40536
South Denver Cardiology
Littleton, Colorado, 80120
VA Healthcare System of Greater Los Angeles
Los Angeles, California, 90073
University of California Los Angeles Pulmonary Division
Los Angeles, California, 90095
Cedars-Sinai Medical Center
Los Angeles, California, 90211
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, 40202
Texas Tech University Health Sciences Center
Lubbock, Texas, 79905
WellStar Medical Group
Marietta, Georgia, 30060
Loyola University Medical Center
Maywood, Illinois, 60153
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
West Virginia University Hospital
Morgantown, West Virginia, 26506
Intermountain Medical Center
Murray, Utah, 84143
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2650
Mount Sinai Medical Center
New York, New York, 10029
Barnabas Health Lung Center
Newark, New Jersey, 07112
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803
Florida Hospital
Orlando, Florida, 32806
OSF HealthCare
Peoria, Illinois, 61614
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
The Oregon Clinic
Portland, Oregon, 97225
Virginia Commonwealth University
Richmond, Virginia, 23298
Carilion Clinic
Roanoke, Virginia, 24014
University of California - Davis Medical Center
Sacramento, California, 95817
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Chest Medicine Associates
South Portland, Maine, 04106
Providence Medical Research Center
Spokane, Washington, 99204
Pulmonary Health Physicians, PC
Syracuse, New York, 13066
University of South Florida ; Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10461
University of Toldedo Medical Center
Toledo, Ohio, 43614
University of Arizona
Tucson, Arizona, 85724
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Medical Faculty Associates, George Washington University
Washington D.C., District of Columbia, 20037
Iowa Heart Center
West Des Moines, Iowa, 50266
Cleveland Clinic of Florida
Weston, Florida, 33331
About this study
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
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.
Read the 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.
- Being tested
- Oral treprostinil
- Keywords
- Pulmonary Hypertension, HFpEF, 6-Minute Walk Test, Oral Treprostinil
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral treprostinilDrug
Also called Treprostinil diethanolamine, Treprostinil diolamine
Sustained-release oral tablets for TID administration
| Study group | Role | What they receive |
|---|---|---|
| Oral treprostinil | Experimental | Sustained-release tablets for TID administration Receives: Drug: Oral treprostinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through study completion, up to approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start30 Jan 2018
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Why it stopped: Terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Hypertension Associated With HFpEFStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mardi Gomberg-Maitland, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043651
- Sponsor's protocol ID
- TDE-HF-302
- Status last verified
- Sep 2020
- First submitted
- 31 Jan 2017
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03043651
- Acronym / sponsor ID
- TDE-HF-302
- Keywords
- Pulmonary Hypertension, HFpEF, 6-Minute Walk Test, Oral Treprostinil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by Sponsor
- Enrolment
- 48 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral treprostinil | Experimental | Drug: Oral treprostinilSustained-release tablets for TID administration |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral treprostinilAlso: Treprostinil diethanolamine, Treprostinil diolamineSustained-release oral tablets for TID administration | Drug | Oral treprostinil |
Primary outcome
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301
Time frame: Baseline through study completion, up to approximately 25 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension Associated With HFpEF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mardi Gomberg-Maitland, MD principal investigator
George Washington University
82 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral treprostinil in people with Pulmonary Hypertension Associated With HFpEF, run by United Therapeutics at 82 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301 (time frame: Baseline through study completion, up to approximately 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.