Safety Study in Outpatient Japanese Children With ADHD

Phase 2CompletedNCT00485628

Eli Lilly and Company37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Atomoxetine HydrochlorideDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, Japan

Outcomes

Primary Outcomes

The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years.

Secondary Outcomes

To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy.

To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine

Data from ClinicalTrials.gov

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