Study Phase 3

Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subject (RUBATO OL)

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesPharmacological SubgroupOther AntihypertensivesChemical SubgroupAntihypertensives for Pulmonary Arterial HypertensionCondition StudiedCongenital Heart Disease
Sponsor Protocol NumberAC-055H302Enrollment112Data PartnerJohnson & Johnson% Female30.6%Mean/Median Age (Years)25.1% White78.4%

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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