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MK-0653, ezetimibe

Phase 3

Hypercholesterolaemia | 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,496
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00328523TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)PHASE3 COMPLETED 1,496 — — Jun 1, 2004Jan 1, 2006Aug 15, 2024 - —
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Study Endpoints
Primary Endpoints
Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
Secondary Endpoints
Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK-0653, ezetimibeDRUG -
Duration of Treatment: 3 monthsDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations). Exclusion Criteria: * pregnant or breast feeding women * Lipid-lowering agents including hmg-coa reductase inhibitors ot...

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