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NCT04647383 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT04647383 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 63 participants.
The verdict
NCT04647383, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to \[\>=\] 45 to less than \[\<\] 65 years; elderly \>=65 to 90 years) with moderate to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults \>=45 to \<65 years; elderly \>=65 to 90 years) with moderate to severe chronic obstructive pulmonary disease (COPD) compared with placebo.
Interventions
- DRUG Placebo
- DRUG Lemborexant 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-01-06 |
| Est. Completion | 2022-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04647383
The ClinicalTrials.gov registry entry for NCT04647383 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 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 Placebo is the first listed.
NCT04647383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04647383 about?
NCT04647383 is a clinical study titled "A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease". The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to \[\>=\] 45 to less than \[\<\] 65 years; elderly \>=65 to 90 years) with moderate to severe obstructi...
What is the current status of trial NCT04647383?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2021-01-06. Estimated completion is 2022-02-10.
What interventions are being tested in trial NCT04647383?
The interventions under investigation include: Placebo (DRUG), Lemborexant 10 mg (DRUG).
Who is sponsoring clinical trial NCT04647383?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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