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

Study Overview
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Brief Summary
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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).

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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Atomoxetine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atomoxetine<br>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 | Drug: Atomoxetine hydrochloride<br>* 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<br>* Other names: Strattera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events for Long Term Safety and Tolerability | Details on the actual adverse events are presented in the Reported Adverse Events Section. | Baseline through 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years | 
| Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) | Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years | 
| Cytochrome P450 2D6 (CYP2D6) Phenotype Status | 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. | Over 1 year |