Study Phase 3

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesCondition StudiedIdiopathic Pulmonary Fibrosis, Scleroderma, SystemicChemical SubgroupsN/APharmacological SubgroupsN/A
Sponsor Protocol NumberAC-052-330 (BUILD 2)Enrollment163Data PartnerJohnson & Johnson% Female73.2%Mean/Median Age (Years)52.2% White80.4%

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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