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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 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 84 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03037580
The ClinicalTrials.gov registry entry for NCT03037580 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03037580 reports 0 study locations.
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.
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