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NCT03037580 · ClinicalTrials.gov registry record · Phase 3
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
A Phase 3 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT03037580: Clinical Trial Phase 3 study, sponsored by United Therapeutics.
NCT03037580 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03037580, a Phase 3 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
This was a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects took the initial dose of study drug at the study site on the day of randomization. Subjects returned to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The duration of study participation was approximately 28 weeks from Screening until study completion (includes a 30-day Screening Phase and 24-week Treatment Phase). The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment. As only a small portion of the anticipated total subjects had been enrolled, with many terminating early due to the study termination, there was a limited ability to explore the effect of oral treprostinil in this indication in this study.
Primary Outcome
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Interventions
- DRUG Placebo
- DRUG Oral treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2019-12-03 |
| Phase | Phase 3 |
Why NCT03037580 stopped before completion
NCT03037580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03037580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03037580 about?
NCT03037580 is a clinical study titled "Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction". This was a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects took t...
What is the current status of trial NCT03037580?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2017-08-15. Estimated completion is 2019-12-03.
What interventions are being tested in trial NCT03037580?
The interventions under investigation include: Placebo (DRUG), Oral treprostinil (DRUG).
Who is sponsoring clinical trial NCT03037580?
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 NCT03037580's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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