Study Phase 3

Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects (RUBATO DB)

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesPharmacological SubgroupOther AntihypertensivesChemical SubgroupAntihypertensives for Pulmonary Arterial HypertensionCondition StudiedCongenital Heart Disease
Sponsor Protocol NumberAC-055H301Enrollment142Data PartnerJohnson & Johnson% Female35.0%Mean/Median Age (Years)23.9% White78.1%

Supporting Documentation

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

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.