Study Phase 3

A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed, Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes Associated With Bipolar I Disorder

Trial Information

Generic NamePaliperidoneProduct NameINVEGA®Therapeutic AreaBehaviors and Mental DisordersEnrollment493% Female42%% White68%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberR076477-BIM-3002Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)39

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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