Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Phase 2
Completed
- Conditions
- Attention Deficit Hyperactivity Disorder
- Registration Number
- NCT00191295
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- Patients are diagnosed with ADHD
- Patients must be able to swallow capsules
- Patients must be of normal intelligence
Exclusion Criteria
- Patients who weigh less than 15 kg or more than 75 kg
- Patients with organic brain disease (for example, dementia or traumatic brain injury residual)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored
- Secondary Outcome Measures
Name Time Method Relationship between atomoxetine doses and both efficacy and safety variables Plasma concentration of atomoxetine and its metabolites Changes on ADHD RS-IV-J-School Version score
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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇯🇵Wakayama, Japan