Study Phase 3

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment188% Female78.9%% White85.1%
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-331Data PartnerJohnson & JohnsonCondition StudiedScleroderma, SystemicMean/Median Age (Years)49.5

Supporting Documentation

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

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