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OpenTrials
Completed

NCT Number: NCT00485628

Safety Study in Outpatient Japanese Children With ADHD

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

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atomoxetine Hydrochloride

Drug

Primary outcomes

  1. 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

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

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2003
First posted
Jun 13, 2007
Registry last updated
Jun 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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