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
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
- 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.