At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 264 enrolled
Drug / intervention
SHP465 +1 moredrug
Likely dose
SHP465 12.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Multi-center, Placebo Controlled, Dose-Optimization, Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating SHP465 and Placebo for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 264 participants across 36 sites.
Detailed Summary
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2015
Primary CompletionFeb 2016
TodayJul 2026
First PostedJun 9, 2015
Enrollment StartJun 18, 2015
Primary CompletionFeb 16, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.1 years ago
Interventions
SHP465drug
12.5mg and 25mg capsules (one capsule daily)
Placebodrug
Matching placebo capsule that appear identical in size, weight, shape, color