NCT00386581

Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Phase III Multicenter, Randomized, Double-Blind Placebo-Controlled Outpatient Study of Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	atomoxetine
DRUG	placebo

Timeline

• Start date: 2004-07-01
• Completion: 2005-02-01
• First posted: 2006-10-11
• Last updated: 2007-06-12

Locations

1 site across 1 country: Russia