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NCT03775421 · ClinicalTrials.gov registry record · Phase 3
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
A Phase 3 study, sponsored by Actelion.
- Terminated
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT03775421: Clinical Trial Phase 3 study, sponsored by Actelion.
NCT03775421 is a Phase 3 study that was terminated before completion, run by Actelion. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03775421, a Phase 3 study, was terminated before completion, sponsored by Actelion.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.
Primary Outcome
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after end of treatment (EOT) (limits included) within the analysis set was considered to be treatment-emergent.
Interventions
- DRUG macitentan 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2019-04-11 |
| Est. Completion | 2022-01-18 |
| Phase | Phase 3 |
Why NCT03775421 stopped before completion
NCT03775421 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which macitentan 10 mg is the first listed.
NCT03775421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03775421 about?
NCT03775421 is a clinical study titled "An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.". The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of...
What is the current status of trial NCT03775421?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2019-04-11. Estimated completion is 2022-01-18.
What interventions are being tested in trial NCT03775421?
The interventions under investigation include: macitentan 10 mg (DRUG).
Who is sponsoring clinical trial NCT03775421?
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 NCT03775421's enrollment target sits among peer trials
112 1652nd of 2000 higher than 346 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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