Status:

COMPLETED

Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder

Lead Sponsor:

Eli Lilly and Company

Conditions:

Attention Deficit Hyperactivity Disorder

Eligibility:

All Genders

8-11 years

Phase:

PHASE3

Brief Summary

Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with Attention- Deficit/Hyperactivity Disorder

Eligibility Criteria

Inclusion

  • Patients must have ADHD, be psychotropic medication naive and be outpatients who are at least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached their 11 birthday) so that all year testing will be completed before the child reaches age 12.

Exclusion

  • Patients with current or past history of Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder or serious suicidal risk are excluded

Key Trial Info

Start Date :

May 1 2004

Trial Type :

INTERVENTIONAL

End Date :

June 1 2006

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00191880

Start Date

May 1 2004

End Date

June 1 2006

Last Update

August 29 2006

Active Locations (8)

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Page 1 of 2 (8 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Calgary, Canada

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Edmonton, Canada

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

London, Canada

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Montreal, Canada