Status:

COMPLETED

Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes

Lead Sponsor:

Eli Lilly and Company

Conditions:

Attention-Deficit/Hyperactivity Disorder

Eligibility:

All Genders

6-11 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to assess whether changes in the symptoms of ADHD show a relationship with changes in functioning in children with ADHD treated with atomoxetine over a 3-month period.

Eligibility Criteria

Inclusion

  • Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at Visit 1 so that all testing will be completed before the child reaches age 12.
  • Patients must have moderately severe symptoms of ADHD.
  • Patients must be able to swallow study drug capsules.

Exclusion

  • Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
  • Patients must not have taken atomoxetine prior to starting the study.

Key Trial Info

Start Date :

April 1 2005

Trial Type :

INTERVENTIONAL

End Date :

June 1 2006

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00191633

Start Date

April 1 2005

End Date

June 1 2006

Last Update

January 26 2007

Active Locations (19)

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Page 1 of 5 (19 locations)

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.

Calgary, Alberta, Canada

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.

Edmonton, Alberta, Canada

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.

Abbotsford, British Columbia, Canada

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.

Burnaby, British Columbia, Canada