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binodenoson

Phase 3

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

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

Clinical trial landscape

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 being developed for use in Coronary Artery Disease. It is intended to assess cardiac ischemia, as studied in two Phase 3 clinical trials. The drug is not yet approved and remains in clinical development.

What does binodenoson target?

Binodenoson is a small molecule that acts as a coronary vasodilator. It is being studied for its ability to assess cardiac ischemia in patients with Coronary Artery Disease. The specific molecular target has not been disclosed in the available information.

Who makes binodenoson?

Binodenoson is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development for Coronary Artery Disease.

What phase is binodenoson in?

Binodenoson is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, but the drug is not yet available on the market.

What clinical trials is binodenoson in?

Binodenoson has been studied in two completed Phase 3 trials: NCT00944294 and NCT00944970. Both trials assessed the efficacy and safety of binodenoson in evaluating cardiac ischemia in patients with Coronary Artery Disease, with a combined enrollment of 997 participants.

Is binodenoson the same as any other drug?

Binodenoson is a distinct investigational compound developed by Pfizer. No alternative names have been reported for this drug in the available information. It is being studied specifically for its role in assessing cardiac ischemia in Coronary Artery Disease.