Adults 18 to 85, any sex, with Pulmonary Hypertension Associated With HFpEF. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301Primary· 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.
Group
Value
95% CI
Oral Treprostinil
47
Adverse events — posted to ClinicalTrials.gov
Time frame: The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03037580 — Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
· Phase 3
· terminated
Other recruiting trials for Pulmonary Hypertension Associated With HFpEF
Currently open trials in the same condition.
NCT07288398 — LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
· Phase 3
· recruiting
Other United Therapeutics trials
Trials by the same sponsor.
NCT06388421 — DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease
· recruiting
NCT05060315 — Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin
· terminated
NCT05203510 — A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right
· Phase 4
· active not recruiting
NCT05255991 — Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
· Phase 3
· completed
NCT04708782 — Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by United Therapeutics
Last refreshed: 22 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03043651.