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NCT00318448 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
NCT00318448: Completed Phase 3 study, sponsored by Sanofi.
NCT00318448 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 201 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00318448, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
Study Summary
There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD associated insomnia.
Interventions
- DRUG Zolpidem (SL800750)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2006-04 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
What the finished NCT00318448 record still lists
NCT00318448 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Zolpidem (SL800750) is the first listed.
NCT00318448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00318448 about?
NCT00318448 is a clinical study titled "Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia". There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess...
What is the current status of trial NCT00318448?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2006-04. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00318448?
The interventions under investigation include: Zolpidem (SL800750) (DRUG).
Who is sponsoring clinical trial NCT00318448?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00318448's enrollment target sits among peer trials
201 1353rd of 2000 higher than 648 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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