Study Phase 3

Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects (RUBATO DB)

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaEnrollment140% Female35.0%% White78.1%
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-055H301Data PartnerJohnson & JohnsonCondition StudiedCongenital Heart DiseaseMean/Median Age (Years)23.9

Supporting Documentation

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

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