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

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Atomoxetine hydrochloride

• Registration Number: NCT00568685
• Lead Sponsor: Eli Lilly and Company

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-06
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-11-11
• Results First Submitted QC: 2009-11-11
• Results First Posted: 2009-12-14
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)	Atomoxetine hydrochloride	-
Atomoxetine 0.5 mg/kg/day	Atomoxetine hydrochloride	-
Atomoxetine 1.2 mg/kg/day	Atomoxetine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
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	Baseline, Day 42	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).

Secondary Outcome Measures

Name	Time	Method
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	Baseline, Days 7, 14, 42	Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
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	Baseline, Days 7, 14, 42	Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)
Adverse Events Leading to Discontinuation	Baseline to Day 42	Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency
Temperature Change From Baseline to Day 42 Endpoint	Baseline, Day 42
Blood Pressure Change From Baseline to Day 42 Endpoint	Baseline, Day 42
Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary	Baseline to Day 42	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.
Heart Rate Change From Baseline to Day 42 Endpoint	Baseline, Day 42
Weight Change From Baseline to Day 42 Endpoint	Baseline, Day 42

Trial Locations

Locations (1)

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