Study Phase 3

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment742% Female76.1%% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-055-302Data PartnerJohnson & JohnsonCondition StudiedHypertension, Pulmonary, ArterialMean/Median Age (Years)45.6

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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