Study Phase 3

Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment616% Female30.4%% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-321Data PartnerJohnson & JohnsonCondition StudiedIdiopathic Pulmonary FibrosisMean/Median Age (Years)63.8

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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