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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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) 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