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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 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 1,006 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02783729
The ClinicalTrials.gov registry entry for NCT02783729 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,006 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Lemborexant is the first listed.
NCT02783729 reports 0 study locations.
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.
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