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A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose-response phase III A study to evaluate safety and efficacy of Prolonged Release (PR) OROS methylphenidate (18, 36 and ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000730-37

A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose-response phase III A study to evaluate safety and efficacy of Prolonged Release (PR) OROS methylphenidate (18, 36 and 72 mg/day), with open-label extension, in adults with attention deficit/ hyperactivity disorder

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Extrait

The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of Prolonged Release (PR) OROS methylphenidate (18, 36 and 72 mg/day) compared with placebo in adult subjects with attention deficit/hyperactivity disorder (ADHD). The efficacy response will be measured by the change in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale (CAARS), from start of treatment to the end of the double-blind phase.

Critère d'inclusion

  • Attention-Deficit/Hyperactivity Disorder (ADHD)

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