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NCT03043651 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
A Phase 3 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
NCT03043651: Clinical Trial Phase 3 study, sponsored by United Therapeutics.
NCT03043651 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03043651, a Phase 3 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Oral treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2020-03-02 |
| Phase | Phase 3 |
Why NCT03043651 stopped before completion
NCT03043651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Oral treprostinil is the first listed.
NCT03043651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03043651 about?
NCT03043651 is a clinical study titled "Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF". 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...
What is the current status of trial NCT03043651?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2018-01-30. Estimated completion is 2020-03-02.
What interventions are being tested in trial NCT03043651?
The interventions under investigation include: Oral treprostinil (DRUG).
Who is sponsoring clinical trial NCT03043651?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03043651's enrollment target sits among peer trials
48 1862nd of 2000 higher than 134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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