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NCT00914862 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
A Phase 1 study of Insomnia, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 2
- Study locations
NCT00914862: Completed Phase 1 study of Insomnia, sponsored by Takeda.
NCT00914862 is a Phase 1 study of Insomnia that has completed, run by Takeda. The registered enrollment target is 56 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00914862, a Phase 1 study of Insomnia, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.
Primary Outcome
Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.
Conditions Studied
Interventions
- DRUG Ramelteon
Study Locations (2)
Kansas
- - Overland Park
Michigan
- - Kalamazoo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT00914862 record still lists
NCT00914862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Ramelteon is the first listed.
NCT00914862 reports a single indexed study location in Kansas, Michigan.
Frequently Asked Questions
What is clinical trial NCT00914862 about?
NCT00914862 is a clinical study titled "Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults". The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.
What is the current status of trial NCT00914862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2009-11. Estimated completion is 2011-04.
What conditions does trial NCT00914862 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT00914862?
The interventions under investigation include: Ramelteon (DRUG).
Who is sponsoring clinical trial NCT00914862?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00914862 being conducted?
This trial has 2 study locations across Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00914862's enrollment target sits among peer trials
56 95th of 151 higher than 54 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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