Study Phase 4

A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesPharmacological SubgroupOther AntihypertensivesChemical SubgroupAntihypertensives for Pulmonary Arterial HypertensionCondition StudiedPulmonary Arterial Hypertension
Sponsor Protocol NumberAC-052-409Enrollment37Data PartnerJohnson & Johnson% Female67.6%Mean/Median Age (Years)39.8% White92.0%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available
Additional Information

Extension Study to Protocol AC-052-405

Disclaimer

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