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

Stopped early · Phase 3

Conditions studied: Pulmonary Hypertension Associated With HFpEF

In brief

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.

Key facts

Study ID

NCT03043651

Run by

United Therapeutics

People needed

48

Starts

2018-01-30

Expected to finish

2020-03-02

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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
• Cleveland Clinic of Florida — Weston, 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 Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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