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Regadenoson; Optison

Phase 3

Coronary Artery Disease | Small molecule | Cardiovascular |GE HealthCare Technologies Inc.|Last Updated: Oct 8, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01489176Regadenoson Real Time Perfusion Imaging Trial-OptisonPHASE3 COMPLETED 50Jul 31, 2012Dec 1, 2014Oct 8, 20242 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Coronary Stenosis
1 year

Measurements will be analyzed to identify a coronary stenosis \>50% in diameter by quantitative cardiac angiography.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Regadenoson; OptisonEXPERIMENTALUse of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography.
Interventions
NameTypeDescription
Regadenoson; OptisonDRUGA one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female. Age ≥ 30 years. * Resting Left Ventricular Ejection Fraction \> 40% using Simpson's biplane measurement. * Scheduled for coronary angiography within 30 days of the Regadenoson stress test. * Negative urine pregnancy test within 2 hours of ultrasound contrast ad...

Countries:United States
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