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Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191048
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
Comorbid Dyslexia
 Drug: Atomoxetine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks.

Estimated Enrollment: 105
Study Start Date: October 2003
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191048

Locations
United States, California
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
United States, Florida
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
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
United States, Illinois
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
United States, Nevada
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
Las Vegas, Nevada, United States
United States, Oklahoma
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
Oklahoma City, Oklahoma, United States
United States, Tennessee
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
Nashville, Tennessee, United States
United States, Vermont
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
Burlington, Vermont, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00191048     History of Changes
Other Study ID Numbers: 7975, B4Z-US-LYCE
Study First Received: September 12, 2005
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Dyslexia
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Language Disorders
 Communication Disorders
Neurobehavioral Manifestations
Learning Disorders
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013