Study Phase 3

Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330

  • 1 CSR Summary Not Yet Available
  • 1 NCT00319033
  • 1 Primary Citation Not Available
  • Data Specification Not Available

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment132% FemaleN/A% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-332 (BUILD 2 OL)Data PartnerJohnson & JohnsonCondition StudiedScleroderma, SystemicMean/Median Age (Years)N/A

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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