Recent Updates
Recently added Catalysts

MK0653A, ezetimibe simvastatin

Phase 3

Hypercholesterolemia | Small Molecules | Metabolic |Organon & Co.|Trials Updated: Aug 23, 2024

MK0653A, ezetimibe simvastatin target and mechanism

ModalitySmall Molecules

Also known as MK0653A

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials8
Total Enrollment9,981

FDA Designations

No designations recorded

MK0653A, ezetimibe simvastatin clinical trials

MK0653A, ezetimibe simvastatin · 8 trials · 5 indications

Phase 3 8
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
NCT00541697Eze/Simva Switch Study in Diabetics (0653A-807)Diabetes Mellitus, Type 2
COMPLETED648 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
NCT00092664An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)Hypercholesterolemia
COMPLETED1,104 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 MellitusUnlock trial analytics
PHASE3COMPLETED
Eze/Simva Switch Study in Diabetics (0653A-807)
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(COMPLETED)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent reduction in LDL-C from baseline after 6 weeks of treatment
Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment
6 Weeks
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.
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
Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment
6 Weeks
To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks
After 12 weeks of treatment
Unlock Study Endpoints

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 / Duration of Treatment: 6 WeeksDRUG -
Comparator: atorvastatin / Duration of Treatment: 6 WeeksDRUG -
MK0653A (ezetimibe [+] simvastatin)DRUG -
Comparator: fluvastatinDRUG -
Comparator: lovastatinDRUG -
Comparator: pravastatinDRUG -
Comparator: rosuvastatinDRUG -
Comparator: simvastatinDRUG -
MK0653A , ezetimibe (+) simvastatinDRUG -
Duration of Treatment: 6 weeksDRUG -
MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeksDRUG -
Comparators: simvastatin and ezetimibeDRUG -
Unlock Study Design Details

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...

Unlock Eligibility Criteria

Frequently asked questions about MK0653A, ezetimibe simvastatin

What is MK0653A used for?

MK0653A is a combination of ezetimibe and simvastatin studied for hypercholesterolemia and type 2 diabetes mellitus. It is a small molecule therapy developed by Organon & Co. (OGN) and has been investigated in Phase 3 clinical trials for lowering cholesterol in patients with these metabolic conditions.

What does MK0653A target?

MK0653A combines ezetimibe and simvastatin. Ezetimibe targets the intestinal cholesterol absorption pathway, while simvastatin targets HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. Together they reduce LDL cholesterol through complementary mechanisms.

Who makes MK0653A?

MK0653A is developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor of the clinical trials evaluating this ezetimibe and simvastatin combination.

What phase is MK0653A in?

MK0653A is in Phase 3 clinical development. All six of its registered trials have been completed, and there are currently no active trials. The program has enrolled a total of 8,104 participants across its studies.

What clinical trials is MK0653A in?

MK0653A has been evaluated in completed Phase 3 trials including NCT00541697 in type 2 diabetes, NCT00132717 in hypercholesterolemia, NCT00110435 in type 2 diabetes and hypercholesterolemia, and NCT00092690 comparing it to atorvastatin for high cholesterol.

Is MK0653A the same as ezetimibe simvastatin?

Yes, MK0653A is also known as ezetimibe simvastatin, ezetimibe (+) simvastatin, and MK0653A (ezetimibe [+] simvastatin). These names refer to the same fixed-dose combination product studied in the Phase 3 program.