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”

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)

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: 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
• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)
• Active Comparator: Atomoxetine 0.5 mg/kg/day
• Active Comparator: Atomoxetine 1.2 mg/kg/day

Primary Measures

• 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
  • Time Frame: Baseline, Day 42
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: Baseline, Days 7, 14, 42
    Safety Issue?: No
• 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
  • Time Frame: Baseline, Days 7, 14, 42
    Safety Issue?: No
• Adverse Events Leading to Discontinuation
  • Time Frame: Baseline to Day 42
    Safety Issue?: Yes
• Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary
  • Time Frame: Baseline to Day 42
    Safety Issue?: Yes
• Heart Rate Change From Baseline to Day 42 Endpoint
  • Time Frame: Baseline, Day 42
    Safety Issue?: No
• Temperature Change From Baseline to Day 42 Endpoint
  • Time Frame: Baseline, Day 42
    Safety Issue?: No
• Blood Pressure Change From Baseline to Day 42 Endpoint
  • Time Frame: Baseline, Day 42
    Safety Issue?: No
• Weight Change From Baseline to Day 42 Endpoint
  • Time Frame: Baseline, Day 42
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568685

Study ID Number: 11710

ClinicalTrials.gov Identifier: NCT00568685

Health Authority: Korea: Food and Drug Administration

Lilly Clinical Trial Registry