Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
Summary
Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with
recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1).
The double blinded period will last 12 weeks and the treatment open phase will last up to 1
year, and atomoxetine treatment will be administered.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.