Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia

Eli Lilly and Company1 site in 1 country105 target enrollmentOctober 2003

ConditionsAttention-Deficit/Hyperactivity Disorder Comorbid Dyslexia

DrugsAtomoxetine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 105
Locations: 1
Primary Endpoint: To assess the effect of atomoxetine,given for approximately 16 weeks, in the treatment of ADHD with Dyslexia as measured by the ADHDRS-IV-Parent:Inv
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

March 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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