Study Phase 3

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With Attention Deficit/Hyperactivity Disorder

Trial Information

Generic NameMethylphenidate HClProduct NameCONCERTA®Therapeutic AreaBehaviors and Mental DisordersEnrollment402% Female45.6%% White97.5%
Product ClassStimulants/ADHD/AnorexiantsSponsor Protocol Number42603ATT3002Data PartnerJohnson & JohnsonCondition StudiedAttention Deficit Hyperactivity DisorderMean/Median Age (Years)34

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available
Additional Information

CSR Summary for German extension study available here

Approved Data Requests Associated with this Trial

Disclaimer

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