Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder
Public ClinicalTrials.gov record NCT02402166. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-label, Multicenter, Exploratory Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder
Study identification
- NCT ID
- NCT02402166
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Shire
- Industry
- Enrollment
- 24 participants
Conditions and interventions
Interventions
- SPD489 Drug
Drug
Eligibility (public fields only)
- Age range
- 4 Years to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 14, 2015
- Primary completion
- Jun 29, 2016
- Completion
- Jun 29, 2016
- Last update posted
- Jun 7, 2021
2015 – 2016
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AVIDA | Newport Beach | California | 92660 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Center For Psychiatry and Behavioral Medicine In | Las Vegas | Nevada | 89128 | — |
| Duke Child and Family Center | Durham | North Carolina | 27710 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02402166, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 7, 2021 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02402166 live on ClinicalTrials.gov.