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NCT00784654 · ClinicalTrials.gov registry record · Phase 3
Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
NCT00784654: Completed Phase 3 study, sponsored by Shire.
NCT00784654 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 276 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00784654, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
Study Summary
The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months
Primary Outcome
Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and \>= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period. Subjects without an endpoint value were classed as treatment failures.
Interventions
- DRUG Placebo
- DRUG Lisdexamfetamine dimesylate (LDX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2009-01-27 |
| Est. Completion | 2011-10-26 |
| Phase | Phase 3 |
What the finished NCT00784654 record still lists
NCT00784654 is an interventional study that assigns participants to a tested intervention. The registered 276 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 (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00784654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00784654 about?
NCT00784654 is a clinical study titled "Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17". The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months
What is the current status of trial NCT00784654?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2009-01-27. Estimated completion is 2011-10-26.
What interventions are being tested in trial NCT00784654?
The interventions under investigation include: Placebo (DRUG), Lisdexamfetamine dimesylate (LDX) (DRUG).
Who is sponsoring clinical trial NCT00784654?
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 NCT00784654's enrollment target sits among peer trials
276 1202nd of 2000 higher than 795 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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