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NCT03575104 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 924
- Enrollment target
NCT03575104: Completed Phase 3 study, sponsored by Idorsia Pharmaceuticals.
NCT03575104 is a Phase 3 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 924 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03575104, a Phase 3 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 924 participants
- Enrollment target
Study Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Primary Outcome
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Interventions
- OTHER Placebo
- DRUG Daridorexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 924 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2020-05-14 |
| Phase | Phase 3 |
What the finished NCT03575104 record still lists
NCT03575104 is an interventional study that assigns participants to a tested intervention. The registered 924 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03575104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03575104 about?
NCT03575104 is a clinical study titled "Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep". The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
What is the current status of trial NCT03575104?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 924 participants. The study started on 2018-05-29. Estimated completion is 2020-05-14.
What interventions are being tested in trial NCT03575104?
The interventions under investigation include: Placebo (OTHER), Daridorexant (DRUG).
Who is sponsoring clinical trial NCT03575104?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03575104's enrollment target sits among peer trials
924 342nd of 2000 higher than 1,658 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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