Status:

COMPLETED

Long-Term, Open Label Atomoxetine Study

Lead Sponsor:

Eli Lilly and Company

Conditions:

Attention Deficit Hyperactivity Disorder

Eligibility:

All Genders

6-18 years

Phase:

PHASE3

Brief Summary

To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents wi...

Eligibility Criteria

Inclusion

  • Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study
  • Must meet the study criteria for ADHD
  • Must be willing to have blood drawn and to complete other test required for this study

Exclusion

  • allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
  • taking certain medicines that could interact with atomoxetine
  • plan to move too far away from a doctor participating in this study in the next 5 years
  • current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study

Key Trial Info

Start Date :

August 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

1553 Patients enrolled

Trial Details

Trial ID

NCT00190684

Start Date

August 1 2000

End Date

October 1 2009

Last Update

January 17 2011

Active Locations (100)

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Page 1 of 25 (100 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.

Birmingham, Alabama, United States, 35233

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.

Phoenix, Arizona, United States, 85016

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.

El Centro, California, United States, 92243

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.

Irvine, California, United States, 92618