Study Phase 4

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT00317486
  • 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-052-405Enrollment54Data 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
Additional Information

Parent study for AC-052-409

Disclaimer

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