Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

Lilly

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Placebo

Drug: Atomoxetine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485459

8160

B4Z-TW-S010

Details and patient eligibility

About

The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.

Enrollment

106 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
Subjects must be aged 6 to 16 years
Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
Subjects must be able to swallow capsules
Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.

Exclusion criteria

Weigh less than 20 kg or more than 60 kg at study entry
Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.