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Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity — SPD503-315  

Attention Deficit Disorder Clinical Trial

Official title:
Phase 3,Double Blind,Placebo-controlled,Multicentre,Randomised-withdrawal,Long-term Maintenance of Efficacy&Safety Study of Extended-release Guanfacine Hydrochloride in Children/Adolescents Aged 6-17 With ADHD

Clinical Trial Summary

A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada and the US.

Clinical Trial Description

The SPD503-315 clinical program has studied the efficacy, safety, and tolerability of this product in treating symptoms of ADHD in children and adolescents aged 6-17 through short-term, placebo-controlled studies and long-termn, open-label studies. This study will more rigorously assess the long-term maintenance of efficacy using a placebo-controlled, randomised-withdrawal design. To date, all of the completed studies conducted as part of the SPD503 proigram have enrolled subjects from the US. This study is designed to evaluate the long-term maintenance of efficacy of SPD503 for the treatment of ADHD in children aged 6-17 years in Europe, Australia, Canada and US. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03662763
Study type Interventional
Source Maastricht University Medical Center
Contact
Status Completed
Phase Phase 3
Start date September 2011
Completion date December 2013
View Details
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