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A-Phase: tirofiban; Z-Phase simvastatin

Phase 3

Acute Coronary Syndrome | Small molecule | Cardiovascular |Organon & Co.|Last Updated: Aug 15, 2024

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 Enrollment4,497
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00251576Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)PHASE3 COMPLETED 4,497Nov 1, 1999Mar 23, 2004Aug 15, 2024 -
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Study Endpoints
Primary Endpoints
Z-Phase: combined frequency of the following clinical endpoint events: cardiovascular death, MI, readmission for ACS.
Secondary Endpoints
Z-Phase: the incidence of the following endpoints, evaluated individually and as a composite: cardiovascular death, MI, readmission for ACS, coronary revascularization due to documented ischemia and non-hemorrhagic stroke.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
A-Phase: tirofiban; Z-Phase simvastatinDRUG -
Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 yearsDRUG -
Comparator: A-Phase: low molecular weight heparin, unfractionated heparinDRUG -
Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hoursDRUG -
Duration of Treatment: Z-Phase, 2 years.DRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * A-Phase: Chest pain at rest for 10 minutes, EKG changes or elevated cardiac blood work * Z-Phase: elevated cholesterol , plus at least one risk factor ( \> 70 years old, diabetes, history of prior heart or blood vessel disease, chest pain with EKG changes, elevation of cardiac...

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