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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). 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.
Primary Outcome
Time to sleep onset as determined by polysomnography
Interventions
- DRUG Placebo
- DRUG rozerem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT01048242 record still lists
NCT01048242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01048242 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01048242's enrollment target sits among peer trials
27 1936th of 2000 higher than 64 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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