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NCT03714815 · ClinicalTrials.gov registry record · Phase 2
A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
A Phase 2 study, sponsored by Actelion.
- Terminated
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT03714815 is a Phase 2 study that was terminated before completion, run by Actelion. The registered enrollment target is 91 participants.
The verdict
NCT03714815, a Phase 2 study, was terminated before completion, sponsored by Actelion.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.
Interventions
- DRUG macitentan 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2021-10-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03714815
The ClinicalTrials.gov registry entry for NCT03714815 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which macitentan 10 mg is the first listed.
NCT03714815 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03714815 about?
NCT03714815 is a clinical study titled "A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease". The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT0315...
What is the current status of trial NCT03714815?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2018-12-07. Estimated completion is 2021-10-12.
What interventions are being tested in trial NCT03714815?
The interventions under investigation include: macitentan 10 mg (DRUG).
Who is sponsoring clinical trial NCT03714815?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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