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)

  • 1 CSR Summary Not Yet Available
  • 1 NCT00319111
  • 1 Primary Citation Trial has yet to be published
  • Data Specification Not Available

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment151% Female66.2%% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-370 (BENEFIT OL)Data PartnerJohnson & JohnsonCondition StudiedHypertension, Pulmonary, ArterialMean/Median Age (Years)63.1

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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