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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: Clinical Trial Phase 2 study, sponsored by Actelion.
NCT03714815 is a Phase 2 study that was terminated before completion, run by Actelion. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with all-cause deaths up to 30 days after study treatment discontinuation were reported. All-cause deaths are defined as all anticipated and unanticipated deaths due to any cause.
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 |
Why NCT03714815 stopped before completion
NCT03714815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which macitentan 10 mg is the first listed.
NCT03714815 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03714815's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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