Back to resultsSafety Study in Outpatient Japanese Children With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Atomoxetine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility 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
Sites / Locations
- 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.
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485628
Brief Title
Safety Study in Outpatient Japanese Children With ADHD
Official Title
An Open-Label, Dose Titration Safety Study of Atomoxetine Hydrochloride in Outpatient Japanese Children With Attention-Deficit/Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To investigate the symptom scores in the ADHDRS-J at baseline and with atomoxetine therapy.
Title
To evaluate the plasma concentration of atomoxetine, 4-hydroxyatomoxetine and N-desmethylatomoxetine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Tokyo
Country
Japan
12. IPD Sharing Statement
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Safety Study in Outpatient Japanese Children With ADHD
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