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binodenoson

Phase 3

Coronary Artery Disease | Small molecule | Cardiovascular |Pfizer, Inc.|Trials Updated: Jun 1, 2012

binodenoson development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Jul 2009

binodenoson target and mechanism

Molecular targetADORA2A
Target classAgonist
ModalitySmall molecule

Also known as CorVue

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment997

FDA Designations

No designations recorded

binodenoson clinical trials

binodenoson · 2 trials · 1 indication

Phase 3 2
NCT00944970Efficacy and Safety Study of Binodenoson in Assessing Cardiac IschemiaCoronary Artery Disease
COMPLETED578 Analytics
NCT00944294Efficacy and Safety Study of Binodenoson in Assessing Cardiac IschemiaCoronary Artery Disease
COMPLETED419 Analytics
PHASE3COMPLETED
Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Coronary Artery DiseaseUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores
2 to 7 days apart
Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores
2 to 7 days apart
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
2 to 7 days apart
Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores
2 to 7 days apart
Difference in binodenoson and adenosine reader-generated Summed Difference Scores
2 to 7 days apart

Secondary Endpoints

Categorized reader-generated Summed Difference Scores (binodenoson and adenosine)
2 to 7 days apart
Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2)
2 to 7 days apart
Difference in reader-generated Summed Stress Scores (binodenoson and adenosine)
2 to 7 days apart
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
binodenoson then adenosineOTHERbinodenoson (experimental); adenosine (active comparator)
adenosine then binodenosonOTHERadenosine (active comparator); binodenoson (experimental)
adenosine then adenosineACTIVE_COMPARATOR -

Interventions

NameTypeDescription
binodenosonDRUG30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
adenosineDRUG30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Able to understand and sign an informed consent form. Exclusion Criteria: * Women who are of childbearing potential. * Very low likelihood of coronary artery disease (by American Heart Association and American College of Cardiology standards). * Documented history of acute m...

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Frequently asked questions about binodenoson

What is binodenoson used for in coronary artery disease?

Binodenoson is an investigational small molecule developed for use in assessing cardiac ischemia in patients with coronary artery disease. It is studied as a pharmacologic stress agent in cardiac imaging, where it helps evaluate blood flow to the heart muscle during diagnostic testing.

What does binodenoson target?

Binodenoson targets ADORA2A, the adenosine A2A receptor, and acts as an agonist at that receptor. By activating ADORA2A, the drug produces coronary vasodilation, which is the pharmacological effect used to simulate stress during cardiac imaging procedures.

Who is developing binodenoson?

Binodenoson is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer holds the development program for this small molecule adenosine A2A receptor agonist in the cardiovascular therapeutic area.

What phase is binodenoson in?

Binodenoson is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA. Both of its recorded Phase 3 trials have been completed, and no trials are currently active.

What clinical trials is binodenoson in?

Binodenoson has been studied in two completed Phase 3 trials: NCT00944970, which enrolled 578 participants, and NCT00944294, which enrolled 419 participants. Both were randomized, double-blind, controlled studies evaluating efficacy and safety in assessing cardiac ischemia in coronary artery disease patients.

How many patients were enrolled in binodenoson trials?

The binodenoson clinical program enrolled a total of 997 participants across its two completed Phase 3 trials. Both studies were randomized, double-blind, and controlled, and enrolled adults aged 30 years and older with coronary artery disease.