NCT00997984

Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)

A Phase 3, Double-blind, Randomized, Multicenter, Placebo-controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children Aged 6-12 With a Diagnosis of Attention-Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	extended-release guanfacine hydrochloride (SPD503)	dosed in AM
DRUG	placebo	dosed in the AM or PM
DRUG	extended-release guanfacine hydrochloride	Dosed in the PM

Timeline

• Start date: 2009-11-17
• Primary completion: 2010-10-09
• Completion: 2010-10-09
• First posted: 2009-10-20
• Last updated: 2021-06-08
• Results posted: 2011-10-26

Locations

46 sites across 2 countries: United States, Canada