Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for use in myocardial ischemia and coronary artery disease. It is currently in Phase 1 clinical development as an investigational therapy for these cardiovascular conditions.
Regadenoson is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics.
Regadenoson is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to evaluate its safety and pharmacokinetics.
Regadenoson is being studied in a Phase 1 clinical trial with the identifier NCT04604782. This trial is evaluating the safety and pharmacokinetics of Regadenoson in pediatric patients with myocardial ischemia or coronary artery disease, and is currently recruiting participants.
Yes, Regadenoson is being studied in a Phase 1 clinical trial that enrolls pediatric patients as young as 4 weeks old. The trial is evaluating the drug's safety and pharmacokinetics in this population, with a planned enrollment of 54 participants.