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 StudiedArterial, Hypertension, PulmonaryMean/Median Age (Years)58.5

Supporting Documentation

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


Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.