NCT01081145

Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised Withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

Conditions

• Attention-deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Extended-release Guanfacine Hydrochloride	The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on age and weight.
OTHER	Placebo	Matching placebo will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on age and weight.

Timeline

• Start date: 2010-05-11
• Primary completion: 2013-06-03
• Completion: 2013-06-03
• First posted: 2010-03-05
• Last updated: 2021-06-14
• Results posted: 2014-06-09

Locations

81 sites across 10 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom