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

Eli Lilly and Company1 site in 1 country330 target enrollmentDecember 2003

ConditionsAttention Deficit Hyperactivity Disorder

DrugsAtomoxetine Hydrochloride Methylphenidate Hydrochloride

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 330
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

October 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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