Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00486083
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2004-10
• Status Verified: 2007-06
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Last Update Submitted: 2007-06-11
• Study First Posted: 2007-06-13
• Last Update Posted: 2007-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To compare the tolerability of atomoxetine and methylphenidate as assessed by treatment-emergent adverse events
To assess the comparability of the efficacy of atomoxetine and methylphenidate on the Conners' Parent Rating Scale-Revised: Short Form
To compare atomoxetine and methylphenidate on other secondary measures

Trial Locations

Locations (1)

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, Mexico