Study Phase 3

Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT)

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT00319111
  • Notebook for Primary Citation Primary Citation Trial has yet to be published
  • 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 StudiedPulmonary Arterial Hypertension
Sponsor Protocol NumberAC-052-370 (BENEFIT OL)Enrollment151Data PartnerJohnson & Johnson% Female66.2%Mean/Median Age (Years)63.1% WhiteN/A

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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