Clinical Trial

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

Study acronym: Rapiscan PIP

Recruiting Phase 1/2

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

Protocol Amendment History 11 amendments

This ClinicalTrials.gov record has been amended 11 times since 2020-10-21; most recent amendment 2026-04-30.

Status change: Not Yet Recruiting → Recruiting 2021-06-04

Trial Details

NCT Number	NCT04604782
Lead Sponsor	GE Healthcare Collaborators: Covance
Conditions	Myocardial Ischemia, Coronary Artery Disease
Enrollment	54 participants
Start Date	2021-05-20
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-06