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Regadenoson

Phase 3

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

Regadenoson development status

Highest phase Phase 3
Registered trials 6 across 4 sponsors since Sep 2005

Regadenoson target and mechanism

Molecular targetADORA2A
Target classAgonist
ModalitySmall molecule

Also known as Lexiscan, CVT-3146

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

Regadenoson clinical trials

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 developed by Gilead Sciences for use in coronary artery disease. It is studied as a pharmacologic stress agent for myocardial perfusion imaging, a diagnostic procedure that assesses blood flow to the heart muscle in patients being evaluated for coronary artery disease.

What does Regadenoson target?

Regadenoson targets ADORA2A, the adenosine A2A receptor, and acts as an agonist at that receptor. Activation of this receptor produces coronary vasodilation, which increases blood flow and supports the imaging of myocardial perfusion during stress testing in patients with coronary artery disease.

Who makes Regadenoson?

Regadenoson is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company sponsored the Phase 3 clinical program evaluating the agent in patients undergoing myocardial perfusion imaging for coronary artery disease.

What phase is Regadenoson in?

Regadenoson has been evaluated in Phase 3 clinical development. Two Phase 3 trials in coronary artery disease are listed, both of which are completed, with no active trials currently recorded. The program enrolled a total of 2,018 participants across those studies.

What clinical trials is Regadenoson in?

Regadenoson was studied in two completed Phase 3 trials: NCT00208312, known as ADVANCE MPI 2, which enrolled 787 patients, and NCT00208299, known as ADVANCE MPI 1, which enrolled 1,231 patients. Both compared Regadenoson with Adenoscan in patients undergoing myocardial perfusion imaging in the United States.

How were the Regadenoson Phase 3 trials designed?

Both Regadenoson Phase 3 trials were randomized, double-blind, and active-controlled, comparing the agent with Adenoscan in patients undergoing myocardial perfusion imaging. They enrolled adults aged 18 years and older of all sexes in the United States, and neither trial selected patients by biomarker.