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First received: February 01, 2023

Clinical Trial: A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Attention Deficit/Hyperactivity Disorder

Study Type: INTERVENTIONAL


Official Title: A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder

Brief Summary: The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD).The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months.Approximately 100 subjects will be enrolled.Approximately 20 sites will participate.

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