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 AreaCardiovascular SystemProduct ClassAntihypertensivesCondition StudiedPulmonary Arterial HypertensionChemical SubgroupsN/APharmacological SubgroupsN/A
Sponsor Protocol NumberAC-055-404Enrollment85Data PartnerJohnson & Johnson% Female48.2%Mean/Median Age (Years)58.5% White51.8%

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

Disclaimer

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