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NCT00500149 · ClinicalTrials.gov registry record · Phase 3
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
NCT00500149: Completed Phase 3 study, sponsored by Shire.
NCT00500149 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 129 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00500149, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 129 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
Primary Outcome
The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).
Interventions
- DRUG Placebo
- DRUG Vyvanse (lisdexamfetamine dimesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2007-06-13 |
| Est. Completion | 2007-12-05 |
| Phase | Phase 3 |
What the finished NCT00500149 record still lists
NCT00500149 is an interventional study that assigns participants to a tested intervention. The registered 129 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00500149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00500149 about?
NCT00500149 is a clinical study titled "A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)". The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
What is the current status of trial NCT00500149?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2007-06-13. Estimated completion is 2007-12-05.
What interventions are being tested in trial NCT00500149?
The interventions under investigation include: Placebo (DRUG), Vyvanse (lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT00500149?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00500149's enrollment target sits among peer trials
129 1597th of 2000 higher than 400 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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