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NCT02466386 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
NCT02466386: Completed Phase 3 study, sponsored by Shire.
NCT02466386 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 113 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02466386, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product.
Interventions
- DRUG SPD489
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2015-08-21 |
| Est. Completion | 2020-01-03 |
| Phase | Phase 3 |
What the finished NCT02466386 record still lists
NCT02466386 is an interventional study that assigns participants to a tested intervention. The registered 113 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which SPD489 is the first listed.
NCT02466386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02466386 about?
NCT02466386 is a clinical study titled "Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder". The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).
What is the current status of trial NCT02466386?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2015-08-21. Estimated completion is 2020-01-03.
What interventions are being tested in trial NCT02466386?
The interventions under investigation include: SPD489 (DRUG).
Who is sponsoring clinical trial NCT02466386?
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 NCT02466386's enrollment target sits among peer trials
113 1651st of 2000 higher than 349 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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