Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)

Group Type ACTIVE_COMPARATOR

Atomoxetine Hydrochloride

Intervention Type DRUG

Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period

Atomoxetine 0.5 mg/kg/day

Group Type ACTIVE_COMPARATOR

Atomoxetine hydrochloride

Intervention Type DRUG

Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period

Atomoxetine 1.2 mg/kg/day

Group Type ACTIVE_COMPARATOR

Atomoxetine hydrochloride

Intervention Type DRUG

Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days.

Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days

Interventions

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Atomoxetine Hydrochloride

Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period

Intervention Type DRUG

Atomoxetine hydrochloride

Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period

Intervention Type DRUG

Atomoxetine hydrochloride

Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days.

Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days

Intervention Type DRUG

Other Intervention Names

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LY139603 Strattera LY139603 Strattera LY139603 Strattera

Eligibility Criteria

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Inclusion Criteria

* Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit.
* Patients must have ADHD, based on the accepted criteria for that disease
* Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made
* Patients must be able to swallow capsules
* Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations

Exclusion Criteria

* Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency
* Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment
* Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk
* Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No