At a glance
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A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents
In Brief
A Phase 3 clinical trial evaluating Atomoxetine and Other standard therapy for ADHD for Attention Deficit Hyperactivity Disorder. Completed, enrolled 399 participants across 35 sites in 9 countries.
Detailed Summary
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.
Study Details
Timeline
Interventions
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension