Safety Study in Outpatient Japanese Children With ADHD

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485628
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
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 September 22, 2014