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

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT00319033
  • Notebook for Primary Citation Primary Citation Not Available
  • Spreadsheet for Data Specification Data Specification Not Yet Available

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesPharmacological SubgroupOther AntihypertensivesChemical SubgroupAntihypertensives for Pulmonary Arterial HypertensionCondition StudiedScleroderma, Systemic
Sponsor Protocol NumberAC-052-332 (BUILD 2 OL)Enrollment132Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)N/A% WhiteN/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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