Study Phase 4

A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaHeart and Blood DiseasesEnrollment85% Female48.2%% White51.8%
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-055-404Data PartnerJohnson & JohnsonCondition StudiedPulmonary Arterial HypertensionMean/Median Age (Years)58.5

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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