Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD
NCT ID: NCT00486083
Last Updated: 2007-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2003-12-31
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Atomoxetine Hydrochloride
Methylphenidate Hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
16 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
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.
Seoul, , South Korea
Countries
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Other Identifiers
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B4Z-MC-LYBR
Identifier Type: -
Identifier Source: secondary_id
6934
Identifier Type: -
Identifier Source: org_study_id