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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 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 48 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03043651
The ClinicalTrials.gov registry entry for NCT03043651 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 48 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 1 intervention - of which Oral treprostinil is the first listed.
NCT03043651 reports 0 study locations.
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.
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