A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients
← catalyst calendarNCT04604782 · readout ≤ 134 d
Sponsored by GE Healthcare (industry) · GEHC — their whole pipeline →. With Covance.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Diagnostic
Enrollment
54estimated
Sites
5
Countries
France, Greece, Italy +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-05-20 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2020-10-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Myocardial Ischemia
- Coronary Artery Disease
Intervention
- Drug: Regadenoson — also filed as Rapiscan
Primary outcomes
what the primary-completion date above is the date OFOccurrence of Adverse Events (AEs) following administration of Regadenoson
measured 70 hours after Regadenoson administration
Changes in physical examinations following administration of Regadenoson
measured Baseline and 2 hours after Regadenoson administration
Changes in physical examinations following administration of Regadenoson
measured Baseline and 2 hours after Regadenoson administration
Changes in oxygen saturation following administration of Regadenoson
measured Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration
Changes in blood pressure in mmHg following administration of Regadenoson
measured Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration
Changes in heart rate as bpm following administration of Regadenoson
measured Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration
Changes in body temperature (as degree C) following administration of Regadenoson
measured Baseline and 2 hours after Regadenoson administration
Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of Regadenoson
measured Baseline, 1 and 2 hours after Regadenoson administration
Changes in serum chemistry following administration of regadenoson
measured Baseline and 2 hours after Regadenoson administration
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.
measured 1, 3, 5, 10, and 20 minutes and 1 and 2 hours post Regadenoson administration
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