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NCT00671086 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Ramelteon in Subjects With Chronic Insomnia
A Phase 3 study of Sleep Initiation and Maintenance Disorders, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,213
- Enrollment target
- 20
- Study locations
NCT00671086: Completed Phase 3 study of Sleep Initiation and Maintenance Disorders, sponsored by Takeda.
NCT00671086 is a Phase 3 study of Sleep Initiation and Maintenance Disorders that has completed, run by Takeda. The registered enrollment target is 1,213 participants, above the 226-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (437% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00671086, a Phase 3 study of Sleep Initiation and Maintenance Disorders, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,213 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.
Conditions Studied
Interventions
- DRUG Ramelteon
Study Locations (20)
California
- - Anaheim
- - Burbank
- - Cerritos
- - Irvine
- - La Jolla
- - La Mesa
- - Lafayette
- - Murrieta
- - Newport Beach
- - Northridge
- - Redlands
- - Riverside
- - San Diego
- - San Francisco
Alabama
- - Birmingham
- - Mobile
Arizona
- - Phoenix
- - Tempe
Arkansas
- - Hot Springs
- - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,213 participants |
| Start Date | 2003-02 |
| Est. Completion | 2004-09 |
| Phase | Phase 3 |
What the finished NCT00671086 record still lists
NCT00671086 is an interventional study that assigns participants to a tested intervention. Its 1,213 participants enrollment target places it among the larger protocols in the corpus, above the 226-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (437% higher).
The record links to 1 condition, with Sleep Initiation and Maintenance Disorders appearing as the primary indexed condition, and to 1 intervention - of which Ramelteon is the first listed.
NCT00671086 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00671086 about?
NCT00671086 is a clinical study titled "Efficacy of Ramelteon in Subjects With Chronic Insomnia". The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.
What is the current status of trial NCT00671086?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,213 participants. The study started on 2003-02. Estimated completion is 2004-09.
What conditions does trial NCT00671086 study?
This clinical trial studies the following conditions: Sleep Initiation and Maintenance Disorders.
What interventions are being tested in trial NCT00671086?
The interventions under investigation include: Ramelteon (DRUG).
Who is sponsoring clinical trial NCT00671086?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00671086 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Initiation and Maintenance Disorders
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 NCT00671086's enrollment target sits among peer trials
1,213 1st of 19 higher than 19 of 19 other Sleep Initiation and Maintenance Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Initiation and Maintenance Disorders 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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