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A 7 week multicenter, double-blind, randomized, placebo-controlled cross-over evaluation of the efficacy and safety of a modified-release oral dosage form of methylphenidate-HCl, Ritalin LA® (20 mg, q...

Update Il y a 4 ans
Reference: EUCTR2005-003002-28

A 7 week multicenter, double-blind, randomized, placebo-controlled cross-over evaluation of the efficacy and safety of a modified-release oral dosage form of methylphenidate-HCl, Ritalin LA® (20 mg, q.d.) compared to Medikinet® ret. (20mg, q.d.) in children with attention deficit hyperactivity disorder (ADHD) aged 6 - 14

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Extract

The primary objective of the study is to demonstrate the efficacy of Ritalin LA 20 mg in children with ADHD aged 6-14 by testing the hypothesis that Ritalin LA 20 mg is superior to placebo and is clinically not inferior to Medikinet ret. 20mg retard over three ratings of the SKAMP Combined rating performed at 10:30 am, at 12:00 am and at 1:30 pm in a laboratory classroom setting.

Inclusion criteria

  • Attention Deficit Hyperactivity Disorder

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