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NCT00671125 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy of Ramelteon in Adults With Chronic Insomnia
A Phase 3 study of Chronic Insomnia, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
- 20
- Study locations
NCT00671125: Completed Phase 3 study of Chronic Insomnia, sponsored by Takeda.
NCT00671125 is a Phase 3 study of Chronic Insomnia that has completed, run by Takeda. The registered enrollment target is 405 participants, below the 25,362-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00671125, a Phase 3 study of Chronic Insomnia, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ramelteon
Study Locations (20)
California
- - Anaheim
- - Oakland
- - San Diego
- - San Francisco
- - Santa Monica
Florida
- - Miami
- - Pembroke Pines
Alabama
- - Birmingham
Arizona
- - Scottsdale
Arkansas
- - Hot Springs
Georgia
- - Atlanta
Illinois
- - Chicago
Kansas
- - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2003-01 |
| Est. Completion | 2003-09 |
| Phase | Phase 3 |
What the finished NCT00671125 record still lists
NCT00671125 is an interventional study that assigns participants to a tested intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 25,362-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Chronic Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00671125 names 20 study sites across 15 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00671125 about?
NCT00671125 is a clinical study titled "Study of Efficacy of Ramelteon in Adults With Chronic Insomnia". The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep
What is the current status of trial NCT00671125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2003-01. Estimated completion is 2003-09.
What conditions does trial NCT00671125 study?
This clinical trial studies the following conditions: Chronic Insomnia.
What interventions are being tested in trial NCT00671125?
The interventions under investigation include: Placebo (DRUG), Ramelteon (DRUG).
Who is sponsoring clinical trial NCT00671125?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00671125 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00671125's enrollment target sits among peer trials
405 2nd of 11 the highest of 11 other Chronic Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Insomnia 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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