An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday

• Diagnosis of ADHD

• Normal intelligence

Exclusion Criteria:

• Weigh less than 20 kg or more than 60 kg at study entry

• Other relevant psychiatric diagnoses

• Are at serious suicidal risk as determined by the investigator

• Have a history of severe allergies

• Alcohol or drug abuse within the past 3 months