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NCT04009577 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT04009577 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 53 participants.
The verdict
NCT04009577, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the proportion of adult \[greater than or equal to (\>=) 18 years\] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition to lemborexant 5 milligram (mg) (LEM5) or 10 mg (LEM10) after 2 weeks of receiving LEM.
Interventions
- DRUG LEM 5 mg
- DRUG LEM 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2020-06-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04009577
The ClinicalTrials.gov registry entry for NCT04009577 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 53 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 2 interventions - of which LEM 5 mg is the first listed.
NCT04009577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04009577 about?
NCT04009577 is a clinical study titled "A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia". The primary objective of the study is to evaluate the proportion of adult \[greater than or equal to (\>=) 18 years\] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition t...
What is the current status of trial NCT04009577?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2019-07-15. Estimated completion is 2020-06-26.
What interventions are being tested in trial NCT04009577?
The interventions under investigation include: LEM 5 mg (DRUG), LEM 10 mg (DRUG).
Who is sponsoring clinical trial NCT04009577?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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