Study Phase 3

Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT00319696
  • Notebook for Primary Citation Primary Citation Not Available
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment116% Female75%% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-333 (RAPIDS-2 OL)Data PartnerJohnson & JohnsonCondition StudiedScleroderma, SystemicMean/Median Age (Years)49.3

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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