Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Atomoxetine Hydrochloride (Drug); Methylphenidate Hydrochloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate
hydrochloride in pediatric patients with ADHD.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: To compare the tolerability of atomoxetine and methylphenidate as assessed by treatment-emergent adverse eventsTo 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
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
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., Shanghai, China
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., Seoul, Korea, Republic of
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
Additional Information
Lilly Clinical Trial Registry
Starting date: December 2003
Last updated: June 11, 2007
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