Safety Study in Outpatient Japanese Children With ADHD

This study has been completed.

First Received: June 11, 2007 No Changes Posted

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00485628

Purpose

Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine Hydrochloride	Phase II

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

The primary objective of the study is to assess whether treatment with 1.8 mg/kg/day of atomoxetine will be safe and tolerable in a population of Japanese pediatric patients aged 6 through 18 years.

Secondary Outcome Measures:

To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy.
To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine

Enrollment:	37
Study Start Date:	April 2003
Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be 6 - 18 years of age
Patients must meet DSM-IV diagnostic criteria for ADHD
Patient must be able to swallow capsules
Patients must be of normal intelligence
Laboratory results must show no significant abnormalities

Exclusion Criteria:

Patients who weigh less than 15 kg or more than 75 kg at study entry
Patients who have a documented history of bipolar disorder or any history of psychosis
Patients taking any antipsychotic medication within 26 weeks of visit 1
Patients with a severe history of allergies
Patients taking methylphenidate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485628

Locations

Japan
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.
Tokyo, Japan

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

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	5286, B4Z-JE-LYBD
Study First Received:	June 11, 2007
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00485628 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Adrenergic Agents
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 07, 2009