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

Tracking Information

First Received Date ^ICMJE

June 11, 2007

Last Updated Date

June 11, 2007

Start Date ^ICMJE

April 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety Study in Outpatient Japanese Children With ADHD

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

Drug: Atomoxetine Hydrochloride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00485628

Other Study ID Numbers ^ICMJE

5286, B4Z-JE-LYBD

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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