Actively Recruiting
A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients
Led by GE Healthcare · Updated on 2026-05-06
54
Participants Needed
5
Research Sites
288 weeks
Total Duration
On this page
Sponsors
G
GE Healthcare
Lead Sponsor
C
Covance
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adolescent aged 12 to under 18 years, child aged 2 to under 12 years, or infant aged 1 to under 24 months
- Patient weighs at least 3 kg
- Patient requires a clinically indicated pharmacologic stress perfusion CMR test and is considered fit for it by the investigator
- Stable medication regimen for at least 7 days prior to dosing with no changes affecting heart rate or blood pressure
- Patients and parents or legal representatives are likely to comply and complete the study
- Post-menarchal female patients must have a negative urine pregnancy test at screening and pre-dose
- Post-menarchal female patients must practice abstinence or use effective birth control for at least 30 days before enrollment
You will not qualify if you...
- Prior allergic reaction to gadolinium contrast agents, regadenoson, aminophylline, or their components
- Contraindications to MRI including cochlear implants or implanted cardiac devices
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 within 24 hours before exam
- Pregnant or lactating females or females of childbearing potential not using acceptable birth control
- Significant ongoing medical conditions or lab abnormalities that may jeopardize safety
- Patients with 2nd or 3rd degree atrioventricular block or sick sinus syndrome
- Unstable or actively treated bronchoconstrictive or bronchospastic lung disease
- Blood pressure or heart rate outside specified ranges for age cohorts
- Use of experimental drugs or devices within 30 days prior to dosing
- Consumption of methylxanthine-containing products within 48 hours prior to dosing
- Use of aminophylline, theophylline, or dipyridamole within specified timeframes before dosing
- History of alcohol abuse or drug addiction
- Smoking more than 5 cigarettes or equivalent per day without ability to abstain during study
- Positive urine drug screen at screening for specified substances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Paris Public Hospitals System; Necker Hospital for Sick Children
Paris, France, 75015
Terminated
2
Mitera Hospital
Athens, Greece, 15123
Completed
3
Bambino Gesu Children Hospital
Roma, Italy, 00165
Actively Recruiting
4
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS28BJ
Not Yet Recruiting
5
King's College London, Rayne Institute
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
M
Michelle Straszacker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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