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Completed

NCT Number: NCT00191386

Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).

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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 3

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., Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study
  • Patients wish to enter into this study

Exclusion criteria

  • Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval

Treatment and study plan

Atomoxetine Hydrochloride

Drug

0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Other names: LY139603, Strattera

Primary outcomes

  1. Number of Participants With Adverse Events for Long Term Safety and Tolerability

    Time frame: Baseline through 4 years

    Details on the actual adverse events are presented in the Reported Adverse Events Section.

Secondary outcomes

  1. Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score

    Time frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years

    Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.

  2. Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)

    Time frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years

    Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

  3. Cytochrome P450 2D6 (CYP2D6) Phenotype Status

    Time frame: Over 1 year

    Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the *2, *3, *4, *5, *6, *7, *8, and *10 alleles. Metabolizer status was determined by focusing on the normal(wild type, *2), decreased(*10), and defective allele(*3, *4, *5, *6, *7, or *8). PM were assigned to the patients had two defective alleles in any combination of *3, *4, *5, *6, *7, or *8 alleles. EM was all except for PM.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Long-Term Extension, Open-Label Study of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Dec 28, 2010

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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