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NCT01048242 · ClinicalTrials.gov registry record · Phase 3
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
A Phase 3 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
NCT01048242: Completed Phase 3 study, sponsored by University of Pennsylvania.
NCT01048242 is a Phase 3 study that has completed, run by University of Pennsylvania. The registered enrollment target is 27 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01048242, a Phase 3 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
Study Summary
The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.
Interventions
- DRUG Placebo
- DRUG rozerem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01048242
The ClinicalTrials.gov registry entry for NCT01048242 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01048242 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01048242 about?
NCT01048242 is a clinical study titled "Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)". The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects takin...
What is the current status of trial NCT01048242?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2006-07. Estimated completion is 2009-03.
What interventions are being tested in trial NCT01048242?
The interventions under investigation include: Placebo (DRUG), rozerem (DRUG).
Who is sponsoring clinical trial NCT01048242?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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