A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure

Trial Profile

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2017

At a glance

  • Drugs Rivaroxaban (Primary) ; Aspirin
  • Indications Thrombosis
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Acronyms UNIVERSE
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 17 Mar 2017 Planned End Date changed from 1 Feb 2022 to 16 Feb 2022.
    • 17 Mar 2017 Planned primary completion date changed from 1 Feb 2022 to 16 Feb 2022.
    • 23 Nov 2016 Status changed from not yet recruiting to recruiting.
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