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NCT01739400 · ClinicalTrials.gov registry record · Phase 3
Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
A Phase 3 study, sponsored by Actelion.
- Terminated
- Registry status
- Phase 3
- Development phase
- 217
- Enrollment target
NCT01739400: Clinical Trial Phase 3 study, sponsored by Actelion.
NCT01739400 is a Phase 3 study that was terminated before completion, run by Actelion. The registered enrollment target is 217 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01739400, a Phase 3 study, was terminated before completion, sponsored by Actelion.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 217 participants
- Enrollment target
Study Summary
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.
Primary Outcome
NOTE: The MAESTRO-OL study was exploratory in nature and no primary efficacy and safety endpoint were defined in the clinical protocol. This and the other exploratory efficacy outcome measures posted were selected to be reported as a primary endpoints. All efficacy analyses were considered exploratory. The analyses of the exploratory efficacy endpoints focused on the absolute values and on the change from DB baseline to Week 16 in the DB study and to Month 6 and Month 12 in the OL study. For mis
Interventions
- DRUG Macitentan 10 mg tablet, once daily.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2013-09-10 |
| Est. Completion | 2018-01-12 |
| Phase | Phase 3 |
Why NCT01739400 stopped before completion
NCT01739400 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Macitentan 10 mg tablet, once daily. is the first listed.
NCT01739400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01739400 about?
NCT01739400 is a clinical study titled "Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome". Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.
What is the current status of trial NCT01739400?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 217 participants. The study started on 2013-09-10. Estimated completion is 2018-01-12.
What interventions are being tested in trial NCT01739400?
The interventions under investigation include: Macitentan 10 mg tablet, once daily. (DRUG).
Who is sponsoring clinical trial NCT01739400?
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 NCT01739400's enrollment target sits among peer trials
217 1332nd of 2000 higher than 669 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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