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

Lilly

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Atomoxetine hydrochloride

Drug: Atomoxetine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00568685

11710

B4Z-KL-LYEC

Details and patient eligibility

About

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)

Enrollment

153 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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