Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Atomoxetine Hydrochloride (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD

Secondary outcome:

Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo

Compare the reduction in school-related symptoms between atomoxetine and placebo

Assess the safety and tolerability of once-daily dosing of atomoxetine

Minimum age: 6 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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.

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, Taipei, Taiwan

Lilly Clinical Trial Registry

Starting date: February 2004
Ending date: November 2004
Last updated: June 11, 2007