Study Phase 3

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A-DUE)

Trial Information

Generic NameMacitentan and TadalafilProduct NameOPSYNVI®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesPharmacological SubgroupOther AntihypertensivesChemical SubgroupAntihypertensives for Pulmonary Arterial HypertensionCondition StudiedPulmonary Arterial Hypertension
Sponsor Protocol NumberAC-077A301Enrollment187Data PartnerJohnson & Johnson% Female78.0%Mean/Median Age (Years)50.2% White61.8%

Supporting Documentation

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

Disclaimer

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