Study Phase 3

An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder

Trial Information

Generic NameMethylphenidate HClProduct NameCONCERTA®Therapeutic AreaBehaviors and Mental DisordersEnrollment560% Female48%% WhiteN/A
Product ClassStimulants/ADHD/AnorexiantsSponsor Protocol Number12-304Data PartnerJohnson & JohnsonCondition StudiedAttention Deficit Hyperactivity DisorderMean/Median Age (Years)39.1

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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