Status:
COMPLETED
Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention-Deficit/Hyperactivity Disorder
Comorbid Dyslexia
Eligibility:
All Genders
10-16 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.
Eligibility Criteria
Inclusion
- Patients with ADHD only or ADHD and Dyslexia
- At least 10 years old and no more than 16 years old
- IQ score of 80 or more
- Must be able to swallow capsules
Exclusion
- Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Weigh less than 25 kg or greater than 70 kg
- Pregnant or breast feeding
- Documented history of bipolar I or II disorder, or psychosis
- Documented history of autism, Asperger's syndrome or pervasive developmental disorder
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00191048
Start Date
October 1 2003
End Date
March 1 2006
Last Update
January 26 2007
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 physician
Rolling Hills Estate, California, United States
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 physician
Maitland, Florida, United States
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 physician
Miami, Florida, United States
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 physician
Libertyville, Illinois, United States