Study Phase 3

A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder

Trial Information

Generic NameMethylphenidate HClProduct NameCONCERTA®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsCondition StudiedAttention Deficit Hyperactivity DisorderChemical SubgroupsN/APharmacological SubgroupsN/A
Sponsor Protocol Number42603ATT3013Enrollment279Data PartnerJohnson & Johnson% Female47.7%Mean/Median Age (Years)37.5% White95.7%

Supporting Documentation

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

Approved Data Requests Associated with this Trial

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