Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Atomoxetine Hydrochloride; Drug: Methylphenidate Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486083

B4Z-MC-LYBR

6934 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 330 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind