Study Phase 3

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment265% Female81.9%% White72.8%
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-055C302Data PartnerJohnson & JohnsonCondition StudiedScleroderma, SystemicMean/Median Age (Years)49.6

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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