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Clinical trial

A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)

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Last updated:23rd May 2008
The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70mg/day) in the treatment of children and adolescents (6 -17 years of age inclusive at the time of consent for the antecedent study, SPD489-325) diagnosed with moderately symptomatic ADHD. The evaluation of safety will be based on the occurrence of treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure and pulse, electrocardiogram (ECG) results, clinical laboratory test results, and physical examination findings.
Category Value
Study start date 2008-05-23

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