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Clinical Trials/NCT00485628
NCT00485628CompletedPhase 2

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 enrollmentStarted: April 1, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
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.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry

Study Sites (1)

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