Safety Study in Outpatient Japanese Children With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485628
• Other study ID #: 5286
• Secondary ID: B4Z-JE-LYBD
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: April 2003
• Est. completion date: October 2003

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Atomoxetine Hydrochloride

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy.
Secondary	To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine

External Links

•   Lilly Clinical Trial Registry