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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of atomoxetine hydrochloride in ADHD treatment compared to methylphenidate?
What is the comparative effectiveness of atomoxetine and methylphenidate in pediatric ADHD phase 3 trials?
Which biomarkers predict differential response to atomoxetine vs methylphenidate in ADHD patients?
What are the adverse event profiles of atomoxetine and methylphenidate in pediatric ADHD populations?
How does Eli Lilly's atomoxetine compare to other SNRI/NRI compounds in ADHD therapeutic efficacy?
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
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