Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Actelion. The registered enrollment target is 112 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03775421
The ClinicalTrials.gov registry entry for NCT03775421 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 112 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.
NCT03775421 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.