Study Phase 4

Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesCondition StudiedPulmonary Arterial HypertensionChemical SubgroupsN/APharmacological SubgroupsN/A
Sponsor Protocol NumberAC-052-414 (COMPASS-2)Enrollment334Data PartnerJohnson & Johnson% Female75.7%Mean/Median Age (Years)53.9% White88.6%

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

Disclaimer

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