A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients
Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics
(PD) study of the vasodilator regadenoson in 3 paediatric age groups for whom a pharmacologic
stress perfusion CMR test is clinically indicated; adolescents aged 12 to <18 years (Cohort
A), children aged 2 to <12 years (Cohort B), and infants aged 1 to <24 months and who weigh
at least 3 kg (Cohort C). Regadenoson will be used as the pharmacologic stress agent in this
study with MPI serving as both surrogate pharmacodynamic marker of the agent (MPR, MBF) and a
clinically evaluable examination for the patient