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MK0733, simvastatin

Phase 3

Hypercholesterolemia | Small molecule | Metabolic |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 Enrollment571
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092157Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)PHASE3 COMPLETED 571May 1, 2002Mar 4, 2003Aug 15, 2024 -
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Study Endpoints
Primary Endpoints
Fasting triglyceride levels at 12 weeks.
Secondary Endpoints
Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0733, simvastatinDRUG -
Comparator: simvastatinDRUG -
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Elevated cholesterol level Exclusion Criteria: * Liver disease * Known allergies to study drugs

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