Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rapiscan
Regadenoson · 1 trial · 2 indications
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.
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.
The occurrence of post-administration vital sign values outside the normal limits will be summarized.
The occurrence of post-administration vital sign values outside the normal limits will be summarized.
The occurrence of post-administration vital sign values outside the normal limits will be summarized.
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.
Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (RR, QT, QTcF\[Fridericia\])
The occurrence of post-administration clinical laboratory values outside the normal limits will be summarized.
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.
| Arm | Type | Description |
|---|---|---|
| adolescents aged 12 to <18 years | EXPERIMENTAL | - |
| children aged 2 to <12 years | EXPERIMENTAL | - |
| infants aged 1 to <24 months and who weigh at least 3 kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Regadenoson | DRUG | Regadenoson (Rapiscan®): Single i.v. bolus dose in stress rest CMR |
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...
Regadenoson is a small molecule drug being developed by GE HealthCare Technologies Inc. for myocardial ischemia, a condition in which blood flow to the heart muscle is reduced. It is currently in Phase 1 clinical development. Regadenoson is also studied in coronary artery disease, and it is being evaluated in pediatric patients as young as 4 weeks old.
Regadenoson targets ADORA2A, the adenosine A2A receptor, and acts as an agonist at that receptor. By activating ADORA2A, the drug is designed to produce coronary vasodilation, increasing blood flow through the coronary arteries. This mechanism underlies its development for myocardial ischemia and coronary artery disease.
Regadenoson is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is the sponsor of the clinical program evaluating the drug in cardiovascular indications, including myocardial ischemia and coronary artery disease.
Regadenoson is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for the myocardial ischemia indication described here. The Phase 1 program is focused on evaluating safety and pharmacokinetics, including in pediatric patients.
Regadenoson is being studied in the Phase 1 trial NCT04604782, titled A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients. The trial is recruiting and plans to enroll 54 participants across France, Greece, Italy, and the United Kingdom. It includes patients with myocardial ischemia and coronary artery disease, ages 4 weeks and older.