ADHD Clinical Trial
Official title:
A 7 Week Multicenter, Double-Blind, Randomized, Placebo-Controlled Cross-Over Evaluation of the Efficacy and Safety of Two Different Brands of Modified-Release Oral Dosage Forms of Methylphenidate-HCl (20 mg, q.d.) in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14
Currently two different brands of modified-release formulations are providing 50% immediate
release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and
dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the
other one by Medice (Germany).
The objective of the study is to test the hypothesis that the Novartis product is superior
to placebo and is clinically not inferior to the formulation manufactured by Medice.
Currently two different brands of modified-release formulations are providing 50% immediate
release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and
dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the
other one by Medice (Germany).
The objective of the study is to test the hypothesis that the Novartis product is superior
to placebo and is clinically not inferior to the formulation manufactured by Medice.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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