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RECRUITING
NCT04604782
PHASE1/PHASE2

A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients

Sponsor: GE Healthcare

View on ClinicalTrials.gov

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

Official title: An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Pediatric Patients

Key Details

Gender

All

Age Range

4 Weeks - 18 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2021-05-20

Completion Date

2026-12

Last Updated

2025-07-09

Healthy Volunteers

No

Interventions

DRUG

Regadenoson

Regadenoson (Rapiscan®): Single i.v. bolus dose in stress rest CMR

Locations (5)

Paris Public Hospitals System; Necker Hospital for Sick Children

Paris, France

Mitera Hospital

Athens, Greece

Bambino Gesu Children Hospital

Roma, Italy

Bristol Royal Hospital for Children

Bristol, United Kingdom

King's College London, Rayne Institute

London, United Kingdom