Study Phase 2

A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT02070991
  • Notebook for Primary Citation Primary Citation Not Available
  • Spreadsheet for Data Specification Data Specification Not Yet Available

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaCardiovascular SystemEnrollment60% Female65.1%% White95.2%
Product ClassAntihypertensivesSponsor Protocol NumberAC-055G201Data PartnerJohnson & JohnsonCondition StudiedPulmonary Arterial HypertensionMean/Median Age (Years)71

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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