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pexelizumab in conjunction with CABG

Phase 3

Coronary Artery Disease | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Feb 22, 2018

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment4,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00088179Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)PHASE3 COMPLETED 4,000Jul 1, 2004Oct 1, 2005Feb 22, 2018188 United States, France +2
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Study Endpoints
Primary Endpoints
Reduction in mortality.
Reduction in MI incidence.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
pexelizumab in conjunction with CABGDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites188

Inclusion Criteria: * be at least 18 years of age; * have 2 or more of the following risk factors: • diabetes mellitus; • repeat CABG; • the need for urgent intervention, defined according to the ACC/AHA guidelines as being patients who are required to stay in the hospital due to medical factors...

Countries:United StatesFranceGermanyNetherlands
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