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

NCT00568685 | Completed Phase 3 Results

• 2 other identifiers: 11710B4Z-KL-LYEC
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 3

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)

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Adverse Events Leading to Discontinuation

  Baseline to Day 42

• Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

  Baseline to Day 42

• Heart Rate Change From Baseline to Day 42 Endpoint

  Baseline, Day 42

Study Arms (3)

Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)

ACTIVE COMPARATOR

Drug: Atomoxetine Hydrochloride

Atomoxetine 0.5 mg/kg/day

ACTIVE COMPARATOR

Drug: Atomoxetine hydrochloride

Atomoxetine 1.2 mg/kg/day

ACTIVE COMPARATOR

Drug: Atomoxetine hydrochloride

Interventions

Atomoxetine hydrochloride DRUG

Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period

Also known as: LY139603, Strattera

Atomoxetine 0.2 milligram per kilogram per day (mg/kg/day)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

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.

Bucheon-si, 420-767, South Korea

Location

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.

Incheon, 405-760, South Korea

Location

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, 135-720, South Korea

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 26, 2010
• Results First Posted: December 14, 2009

Record last verified: 2010-01

Locations

KR (3)