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

Recruiting Phase 1 Phase 2 Interventional Study
Myocardial Ischemia Coronary Artery Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
4 Weeks – 18
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Diagnostic
Participants needed
54 (estimated)
Sponsor
GE Healthcare · Industry
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About This Trial
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). …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * \* Male or female adolescent aged from 12 to \<18 years (Cohort A) or child aged from 2 to \<12 years (Cohort B) or infant aged from 1 to \<24 months (Cohort C). * Patient weighs at least 3 kg. * Patients who need to undergo a clinically indicated pharmacologic stress per…
Contacts

Michelle Straszacker

+44 (0) 7827845147

michelle.straszacker@gehealthcare.com

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