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MK0653A, ezetimibe simvastatin

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Organon & Co.|Last Updated: Aug 23, 2024

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,229
FDA Designations
No designations recorded
Clinical trial landscape

MK0653A, ezetimibe simvastatin · 6 trials · 4 indications

Phase 3 6
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)Type 2 Diabetes Mellitus
COMPLETED1,229 Analytics
NCT00132717A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)Hypercholesterolemia
COMPLETED450 Analytics
NCT00090298Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)Hypercholesterolemia
COMPLETED2,815 Analytics
NCT00090168Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(COMPLETED)Hypercholesterolemia
COMPLETED435 Analytics
NCT00092690MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)Hypercholesterolemia
COMPLETED1,902 Analytics
NCT00092651A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)Hypercholesterolemia
COMPLETED1,398 Analytics
PHASE3COMPLETED
A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)
Type 2 Diabetes Mellitus
NCT001104351,229
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PHASE3COMPLETED
A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)
Hypercholesterolemia
NCT00132717450
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PHASE3COMPLETED
Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)
Hypercholesterolemia
NCT000902982,815
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PHASE3COMPLETED
Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(COMPLETED)
Hypercholesterolemia
NCT00090168435
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PHASE3COMPLETED
MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)
Hypercholesterolemia
NCT000926901,902
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PHASE3COMPLETED
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)
Hypercholesterolemia
NCT000926511,398
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Study Endpoints
Primary Endpoints
Percent reduction in LDL-C from baseline after 6 weeks of treatment
Evaluate the effectiveness of MK0653A compared to doubling the statin dose as shown by the low-density lipoprotein cholesterol (LDL-C) values achieved after 12 weeks of treatment
After 12 weeks of treatment
LDL-C lowering efficacy after 6 weeks.
LDL-C lowering
Plasma LDL-C averaged across all doses after 6 weeks
Plasma LDL-C
From baseline to study end point, defined in this study as the last available postbaseline LDL-C measurement, after 12 weeks of treatment.
Secondary Endpoints
Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment
To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks
After 12 weeks of treatment
Safety;changes in TC, non-HDL-C, TG, HDL-C, Apo B, LDL-C/HCL-C ratio.
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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 -
MK0653A (ezetimibe [+] simvastatin)DRUG -
Comparator: fluvastatinDRUG -
Comparator: lovastatinDRUG -
Comparator: pravastatinDRUG -
Comparator: rosuvastatinDRUG -
Comparator: simvastatinDRUG -
MK0653A , ezetimibe (+) simvastatinDRUG -
Duration of Treatment: 6 weeksDRUG -
Comparators: simvastatin and ezetimibeDRUG -
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Eligibility Criteria
Age Range18 Years to 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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