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NCT03153137 · ClinicalTrials.gov registry record · Phase 3
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 142
- Enrollment target
NCT03153137 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 142 participants.
The verdict
NCT03153137, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 142 participants
- Enrollment target
Study Summary
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Interventions
- DRUG Placebo
- DRUG Macitentan 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2017-08-14 |
| Est. Completion | 2021-07-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03153137
The ClinicalTrials.gov registry entry for NCT03153137 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 142 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 2 interventions - of which Placebo is the first listed.
NCT03153137 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03153137 about?
NCT03153137 is a clinical study titled "Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects". The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
What is the current status of trial NCT03153137?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 142 participants. The study started on 2017-08-14. Estimated completion is 2021-07-26.
What interventions are being tested in trial NCT03153137?
The interventions under investigation include: Placebo (DRUG), Macitentan 10 mg (DRUG).
Who is sponsoring clinical trial NCT03153137?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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