Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485459
• Other study ID #: 8160
• Secondary ID: B4Z-TW-S010
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: February 2004
• Est. completion date: November 2004

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Atomoxetine Hydrochloride

• Placebo

Locations

Country	Name	City	State
Taiwan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
Secondary	Compare the reduction in school-related symptoms between atomoxetine and placebo
Secondary	Assess the safety and tolerability of once-daily dosing of atomoxetine

External Links

•   Lilly Clinical Trial Registry