NCT01244490

Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Extended-release Guanfacine Hydrochloride	Tablet, once daily, optimised dose (1mg to 7mg based on age and weight), 6-week maintenance duration on optimised dose.
DRUG	Atomoxetine Hydrochloride	Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose
DRUG	Placebo Comparator	Placebo

Timeline

• Start date: 2011-01-17
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-11-19
• Last updated: 2021-07-02
• Results posted: 2014-07-14

Locations

66 sites across 13 countries: United States, Austria, Canada, France, Germany, Ireland, Italy, Poland, Romania, Spain, Sweden, Ukraine, United Kingdom