Last updated on March 2018

A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed with Attention-deficit/Hyperactivity Disorder

Brief description of study

To evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children (4-5 years of age inclusive) diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).


The evaluation of safety and tolerability will be based on the occurrence of treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure, pulse, weight, height, clinical laboratory evaluations, electrocardiogram (ECG) results, and sleep assessments.

Clinical Study Identifier: TX155149

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