Safety Study in Outpatient Japanese Children With ADHD

Lilly

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Atomoxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00485628

B4Z-JE-LYBD

5286

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)