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binodenoson

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment997
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00944970Efficacy and Safety Study of Binodenoson in Assessing Cardiac IschemiaPHASE3 COMPLETED 578Oct 1, 2005Dec 1, 2006Jun 1, 2012 -
NCT00944294Efficacy and Safety Study of Binodenoson in Assessing Cardiac IschemiaPHASE3 COMPLETED 419Feb 1, 2004Apr 1, 2006Jun 1, 2012 -
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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 — 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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