Study Phase 2

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment80% Female37.5%% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-281Data PartnerJohnson & JohnsonCondition StudiedNeoplasmsMean/Median Age (Years)60.5

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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