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Regadenoson

Phase 3

Coronary Artery Disease | Small molecule | Cardiovascular |Gilead Sciences, Inc.|Last Updated: Nov 26, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment2,018

FDA Designations

No designations recorded

Clinical trial landscape

Regadenoson · 2 trials · 1 indication

Phase 3 2
NCT00208312ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)Coronary Artery Disease
COMPLETED787 Analytics
NCT00208299ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)Coronary Artery Disease
COMPLETED1,231 Analytics
PHASE3COMPLETED
ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Coronary Artery DiseaseUnlock trial analytics
PHASE3COMPLETED
ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects
After radiopharmaceutical administration
Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects
After radiopharmaceutical administration

Secondary Endpoints

Safety and tolerability comparison of regadenoson to Adenoscan
Up to two weeks
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan
After radiopharmaceutical administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRegadenoson
2ACTIVE_COMPARATORAdenoscan

Interventions

NameTypeDescription
RegadenosonDRUG0.4 mg, bolus intravenous injection
AdenosineDRUG0.14 mg/kg/min for 6 minutes, intravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study Exclusion Criteria: * Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study * Pregnant or breast-feeding, or (if pre-men...

Countries:United States
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Frequently asked questions about Regadenoson

What is Regadenoson used for in Coronary Artery Disease?

Regadenoson is a small molecule being developed by Gilead Sciences for use in patients with Coronary Artery Disease undergoing myocardial perfusion imaging (MPI). It is an investigational drug that has completed Phase 3 clinical trials, though it is not yet approved for this use.

What does Regadenoson target?

Regadenoson is a small molecule that acts as a coronary vasodilator. It is used during myocardial perfusion imaging to assess blood flow in patients with Coronary Artery Disease. The drug works by increasing blood flow in healthy coronary arteries, which helps detect areas of reduced flow.

Who makes Regadenoson?

Regadenoson is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Coronary Artery Disease.

What phase is Regadenoson in?

Regadenoson is in Phase 3 clinical development. It has completed two Phase 3 trials, both of which were randomized, double-blind, and active-controlled. The drug is still investigational and has not been approved by regulatory authorities for use in Coronary Artery Disease.

What clinical trials is Regadenoson in?

Regadenoson has been studied in two completed Phase 3 trials: NCT00208299 (ADVANCE MPI 1) with 1,231 patients and NCT00208312 (ADVANCE MPI 2) with 787 patients. Both trials compared Regadenoson to Adenoscan in patients undergoing myocardial perfusion imaging for Coronary Artery Disease.

Is Regadenoson the same as Adenoscan?

No, Regadenoson is not the same as Adenoscan. In the ADVANCE MPI trials, Regadenoson was compared against Adenoscan as an active control. Both are used in myocardial perfusion imaging, but they are distinct drugs with different chemical structures and properties.