An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder

Eli Lilly and Company1 site in 1 country37 target enrollmentApril 2003

ConditionsAttention Deficit Hyperactivity Disorder

DrugsAtomoxetine Hydrochloride

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 37
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

October 2003

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility 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

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