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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
Novartis Investigational Site
Freiburg im Breisgau, Germany
Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake
7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl on attention, deportment, behavior and math in children with attention deficit hyperactivity disorder (ADHD) aged 6 - 14
Safety of 7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl
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