Status:
COMPLETED
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
8-11 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) sym...
Eligibility Criteria
Inclusion
- Male or female outpatients between 8 and 11 years of age at study entry
- Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
- Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
- Normal intelligence in the judgment of the investigator
- Must be able to swallow capsules
Exclusion
- Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
- History of seizure disorder or currently taking anticonvulsants for seizure control
- Serious suicidal risk as determined by investigator
- Cardiovascular disease; current or past history of hypertension
- Previous treatment with atomoxetine
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00471354
Start Date
April 1 2007
End Date
November 1 2008
Last Update
January 12 2010
Active Locations (8)
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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 ph
Beijing, China, 100088
2
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 ph
Shanghai, China, 200127
3
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 ph
Pusan, South Korea, 609-739
4
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 ph
Seoul, South Korea, 138-736