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

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 Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Atomoxetine Hydrochloride; Drug: Atomoxetine hydrochloride; Drug: Atomoxetine hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of, 420-767
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • In Cheon, Korea, Republic of, 405-760
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Seoul, Korea, Republic of, 135-720
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)	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; Other Names: LY139603; Strattera
Active Comparator: Atomoxetine 0.5 mg/kg/day	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; Other Names: LY139603; Strattera; 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; Other Names: LY139603; Strattera
Active Comparator: Atomoxetine 1.2 mg/kg/day	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; Other Names: LY139603; Strattera; 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; Other Names: LY139603; 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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 6, 2007

Study Record Updates

• Last Update Posted (Estimate): January 26, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 11710 (Other Identifier: DAIDS ID: 11710); B4Z-KL-LYEC