Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Randomized, Double-Blind Comparison, Safety and Efficacy Trial of Atomoxetine Hydrochloride and Methylphenidate Hydrochloride in Pediatric Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486083
• Other study ID #: 6934
• Secondary ID: B4Z-MC-LYBR
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: December 2003
• Est. completion date: October 2004

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate hydrochloride in pediatric patients with ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• Be at least 6 years of age and not more than 16 years of age at Visit 1

• Must meet DSM-IV criteria for ADHD

• Must be of normal intelligence (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an IQ test)

• Must be able to swallow capsules

• Must have laboratory results that show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)

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

• 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 anti-convulsants for seizure control

• Have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions,including a hypersensitivity to methylphenidate

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

• Methylphenidate Hydrochloride

Locations

Country	Name	City	State
China	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.	Shanghai
Korea, Republic of	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.	Seoul
Mexico	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.	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

China,  Korea, Republic of,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the hypothesis that atomoxetine hydrochloride is non-inferior to methylphenidate hydrochloride in improving ADHD symptoms following an approximately 8-week period of double blind treatment as assessed by a comparison of response rates
Secondary	To compare the tolerability of atomoxetine and methylphenidate as assessed by treatment-emergent adverse events
Secondary	To assess the comparability of the efficacy of atomoxetine and methylphenidate on the Conners' Parent Rating Scale-Revised: Short Form
Secondary	To compare atomoxetine and methylphenidate on other secondary measures

External Links

•   Lilly Clinical Trial Registry