Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter
trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6
through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an
inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured
during once or bi-weekly visits, three times per visit-day, by a computer based Continuous
Performance Test. Following an initial 3-28-day screening and washout phase, patients will be
assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week
atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7
week period at the target dose of 1.2 mg/kg per day.