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NCT02783729 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,006
- Enrollment target
NCT02783729: Completed Phase 3 study, sponsored by Eisai.
NCT02783729 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 1,006 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02783729, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,006 participants
- Enrollment target
Study Summary
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.
Primary Outcome
LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported.
Interventions
- DRUG Lemborexant
- DRUG Zolpidem tartrate
- DRUG Lemborexant-matched placebo
- DRUG Zolpidem-matched placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,006 participants |
| Start Date | 2016-05-31 |
| Est. Completion | 2018-01-30 |
| Phase | Phase 3 |
What the finished NCT02783729 record still lists
NCT02783729 is an interventional study that assigns participants to a tested intervention. Its 1,006 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 4 interventions - of which Lemborexant is the first listed.
NCT02783729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02783729 about?
NCT02783729 is a clinical study titled "Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)". This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with...
What is the current status of trial NCT02783729?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,006 participants. The study started on 2016-05-31. Estimated completion is 2018-01-30.
What interventions are being tested in trial NCT02783729?
The interventions under investigation include: Lemborexant (DRUG), Zolpidem tartrate (DRUG), Lemborexant-matched placebo (DRUG), Zolpidem-matched placebo (DRUG).
Who is sponsoring clinical trial NCT02783729?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02783729's enrollment target sits among peer trials
1,006 295th of 2000 higher than 1,706 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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