Safety Study in Outpatient Japanese Children With ADHD
Phase 2
Completed
- Conditions
- Attention Deficit Hyperactivity Disorder
- Registration Number
- NCT00485628
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
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