Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride; Methylphenidate

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