NCT03325881

Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years

A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Fixed-Dose, Efficacy, and Safety Study of SHP465 in Children Aged 6-12 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	SHP465	SHP465 capsule 6.25 mg orally once daily for 4 weeks
DRUG	Placebo	Placebo matching to SHP465 capsule orally once daily for 4 weeks

Timeline

• Start date: 2017-12-09
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2017-10-30
• Last updated: 2021-06-02
• Results posted: 2019-08-13

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study