NCT02466425

Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	SHP465	12.5mg and 25mg capsules (one capsule daily)
DRUG	Placebo	Matching placebo capsule that appear identical in size, weight, shape, color

Timeline

• Start date: 2015-06-18
• Primary completion: 2016-02-16
• Completion: 2016-02-16
• First posted: 2015-06-09
• Last updated: 2021-06-03
• Results posted: 2017-03-20

Locations

36 sites across 1 country: United States