Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine Hydrochloride; Atomoxetine hydrochloride; Atomoxetine hydrochloride
Intervention description: Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period; Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period; 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 MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      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)
    

Eligibility criteria:

        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