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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

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Regadenoson; Optison · 1 trial · 2 indications

Phase 3 1
NCT01489176Regadenoson Real Time Perfusion Imaging Trial-OptisonCoronary Artery Disease
COMPLETED50 Analytics
PHASE3COMPLETED
Regadenoson Real Time Perfusion Imaging Trial-Optison
Coronary Artery DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about Regadenoson; Optison

What is Regadenoson Optison used for?

Regadenoson Optison is used for coronary artery disease and myocardial perfusion abnormalities. It is a small molecule cardiovascular therapy being developed by GE HealthCare Technologies Inc. (GEHC). The drug is currently in Phase 3 clinical development, with one completed trial involving 50 participants in the United States.

What does Regadenoson Optison target?

Regadenoson Optison is a small molecule cardiovascular therapy. It is being studied for use in coronary artery disease and myocardial perfusion abnormalities. The drug is in Phase 3 clinical development, with a completed trial (NCT01489176) that enrolled 50 patients in the United States.

Who makes Regadenoson Optison?

GE HealthCare Technologies Inc. (GEHC) is developing Regadenoson Optison. The drug is a small molecule cardiovascular therapy in Phase 3 clinical development for coronary artery disease and myocardial perfusion abnormalities. One clinical trial has been completed with 50 participants.

What phase is Regadenoson Optison in?

Regadenoson Optison is in Phase 3 clinical development. It is an investigational small molecule therapy for coronary artery disease and myocardial perfusion abnormalities. The drug has completed one Phase 3 trial (NCT01489176) with 50 participants in the United States, and it is not yet approved.

What clinical trials is Regadenoson Optison in?

Regadenoson Optison has one completed clinical trial, NCT01489176, titled "Regadenoson Real Time Perfusion Imaging Trial-Optison." This Phase 3 study enrolled 50 participants with coronary artery disease and myocardial perfusion abnormalities in the United States. The trial was uncontrolled and not randomized or double-blinded.

Is Regadenoson Optison the same as Regadenoson or Optison?

Regadenoson Optison is a combination therapy that includes Regadenoson and Optison. It is being developed by GE HealthCare Technologies Inc. (GEHC) for coronary artery disease and myocardial perfusion abnormalities. The drug is in Phase 3 clinical development, with one completed trial involving 50 patients.