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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00914862
The ClinicalTrials.gov registry entry for NCT00914862 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (67% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.