A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
Regadenoson: Regadenoson (Rapiscan®): Single i.v. bolus dose in stress rest CMR
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
Eligibility
Primary outcome measure(s)
- Occurrence of Adverse Events (AEs) following administration of Regadenoson — 70 hours after Regadenoson administration
An overall summary of AEs, SAEs, and Regadenoson-emergent AEs will be presented, coded using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class and preferred term. - Changes in physical examinations following administration of Regadenoson — Baseline and 2 hours after Regadenoson administration
The number of patients with changes in physical examination status from normal at baseline to abnormal at each post-administration time point will be summarized. - Changes in physical examinations following administration of Regadenoson — Baseline and 2 hours after Regadenoson administration
The percentage of patients with changes in physical examination status from normal at baseline to abnormal at each post-administration time point will be summarized. - Changes in oxygen saturation following administration of Regadenoson — Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration
The occurrence of post-administration vital sign values outside the normal limits will be summarized. - Changes in blood pressure in mmHg following administration of Regadenoson — Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration
The occurrence of post-administration vital sign values outside the normal limits will be summarized. - Changes in heart rate as bpm following administration of Regadenoson — Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration
The occurrence of post-administration vital sign values outside the normal limits will be summarized. - Changes in body temperature (as degree C) following administration of Regadenoson — Baseline and 2 hours after Regadenoson administration
The occurrence of post-administration body temperature values outside the normal limits will be summarized by counts and percentages by age group and actual dose. - Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of Regadenoson — Baseline, 1 and 2 hours after Regadenoson administration
Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (RR, QT, QTcF\[Fridericia\]) - Changes in serum chemistry following administration of regadenoson — Baseline and 2 hours after Regadenoson administration
The occurrence of post-administration clinical laboratory values outside the normal limits will be summarized. - Time changes of regadenoson blood concentrations (ng/mL) with a single, body-weight adjusted i.v. dose in 3 paediatric populations: adolescents 12 to <18 years,children 2 to <12 years, and infants 1 to <24 months, and who weigh at least 3kg. — 1, 3, 5, 10, and 20 minutes and 1 and 2 hours post Regadenoson administration
Blood samples for PK assessment will be collected and processed for measurement of Regadenoson blood concentrations. Concentration-time profiles will be evaluated using compartmental methods and a population approach with mixed-effect modelling. A summary will be listed by patient and summarized by age group and actual dose at each time point.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Paris Public Hospitals System; Necker Hospital for Sick Children | Paris | France | Terminated |
| Mitera Hospital | Athens | Greece | Completed |
| Bambino Gesu Children Hospital | Roma | Italy | Recruiting |
| Bristol Royal Hospital for Children | Bristol | United Kingdom | Not Yet Recruiting |
| King's College London, Rayne Institute | London | United Kingdom | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04604782 on ClinicalTrials.gov ↗ ← All trials in France