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MK0653A, ezetimibe simvastatin

Phase 3

Type 2 Diabetes Mellitus | 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 Enrollment1,229
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00110435A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)PHASE3 COMPLETED 1,229May 1, 2005Dec 1, 2005Aug 15, 2024 -
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Study Endpoints
Primary Endpoints
Percent reduction in LDL-C from baseline after 6 weeks of treatment
Secondary Endpoints
Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0653A, ezetimibe (+) simvastatinDRUG -
Duration of Treatment: 4 wk placebo run in then 6 wk activeDRUG -
Comparator: atorvastatinDRUG -
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Eligibility Criteria
Age Range18 Years — 79 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs. Exclusion Criteria: * Type 1 Diabetes Mellitus...

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