Status:
COMPLETED
Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
13-16 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks
Eligibility Criteria
Inclusion
- Patients must have ADHD.
- Must be 13-16 years of age.
- Must be able to swallow capsules.
- Expected to achieve score of 70 or more on IQ test
- Willing and reliable to keep appts. for clinic visits and test
Exclusion
- Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
- Patients who weigh less than 40 kg or greater than 70 kg.
- Patients with documented history of Bipolar I or II disorder, or psychosis
- Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00191035
Start Date
March 1 2004
End Date
November 1 2006
Last Update
December 13 2006
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
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
Pasadena, 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
Rolling Hills Estates, California, 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
Spring Valley, California, 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
Norwich, Connecticut, United States