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

NCT04604782 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-06

No results posted yet for this study

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

Conditions

Interventions

DRUG

Regadenoson

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • David Thompson, MD, PhD · GE Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
4 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France
  • Greece
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04604782 on ClinicalTrials.gov