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First received: December 13, 2022

Clinical Trial: An Efficacy and Safety Study w/ Azstarys® in Children With ADHD

Study Status: Completed

Recruit Status: RECRUITING

Condition: Attention Deficit/Hyperactivity Disorder

Study Type: INTERVENTIONAL


Official Title: A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder

Brief Summary: This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD).Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered.The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD.The study will consist of two randomized and blinded…

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