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
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