Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder
Sponsor: Shire
This PHASE3 trial investigates Attention Deficit Hyperactivity Disorder (ADHD) and is currently completed. Shire leads this study, which shows 13 recorded versions since 2017 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.
Status Flow
Change History
13 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Sep 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Sep 2021 [monthly]
Completed PHASE3
▶ Show 8 earlier versions
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Feb 2020 — Jan 2021 [monthly]
Completed PHASE3
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May 2019 — Feb 2020 [monthly]
Completed PHASE3
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Feb 2019 — May 2019 [monthly]
Completed PHASE3
Status: Recruiting → Completed
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Jul 2018 — Feb 2019 [monthly]
Recruiting PHASE3
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Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE3
-
Dec 2017 — Jun 2018 [monthly]
Recruiting PHASE3
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Oct 2017 — Dec 2017 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Sep 2017 — Oct 2017 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Shire
For direct contact, visit the study record on ClinicalTrials.gov .