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

Study Overview
=================
Brief 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)

Official Title
-----------------
A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine Hydrochloride
* Drug: Atomoxetine hydrochloride
* Drug: Atomoxetine hydrochloride


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)<br> | Drug: Atomoxetine Hydrochloride<br>* Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period<br>* Other names: Strattera;|
| Active Comparator: Atomoxetine 0.5 mg/kg/day<br> | Drug: Atomoxetine hydrochloride<br>* Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period<br>* Other names: Strattera;|
| Active Comparator: Atomoxetine 1.2 mg/kg/day<br> | Drug: Atomoxetine hydrochloride<br>* 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<br>* Other names: Strattera;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score | Measures the 18 symptoms contained in the DSM-IV 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 (no symptoms) to 54 (highly symptomatic). | Baseline, Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | Baseline, Days 7, 14, 42 | 
| Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened) | Baseline, Days 7, 14, 42 | 
| Adverse Events Leading to Discontinuation | Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency | Baseline to Day 42 | 
| Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary | Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required. | Baseline to Day 42 | 
| Heart Rate Change From Baseline to Day 42 Endpoint |  | Baseline, Day 42 | 
| Temperature Change From Baseline to Day 42 Endpoint |  | Baseline, Day 42 | 
| Blood Pressure Change From Baseline to Day 42 Endpoint |  | Baseline, Day 42 | 
| Weight Change From Baseline to Day 42 Endpoint |  | Baseline, Day 42 |