Completed

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

What is being tested

Atomoxetine Hydrochloride

+ Atomoxetine hydrochloride

Drug

Who is being recruted

Attention Deficit Disorder with Hyperactivity+1

+ Mental Disorders

+ Attention Deficit and Disruptive Behavior Disorders

From 6 to 18 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: November 2007

See protocol details

Summary

Principal SponsorEli Lilly and Company

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2007

Actual date on which the first participant was enrolled.

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

NCT00568685

Principal SponsorEli Lilly and Company

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

153 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Attention Deficit Disorder with HyperactivityMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Criteria

5 inclusion criteria required to participate

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

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

Show More Criteria

4 exclusion criteria prevent from participating

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 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

Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Group III

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

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, South KoreaOpen 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 Google Maps

Suspended

Incheon, South Korea

Suspended

Seoul, South Korea

Completed3 Study Centers