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.
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…
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