Safety Study in Outpatient Japanese Children With ADHD

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients must be 6 - 18 years of age

• Patients must meet DSM-IV diagnostic criteria for ADHD

• Patient must be able to swallow capsules

• Patients must be of normal intelligence

• Laboratory results must show no significant abnormalities

Exclusion Criteria:

• Patients who weigh less than 15 kg or more than 75 kg at study entry

• Patients who have a documented history of bipolar disorder or any history of psychosis

• Patients taking any antipsychotic medication within 26 weeks of visit 1

• Patients with a severe history of allergies

• Patients taking methylphenidate