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MK-0653, ezetimibe

Phase 3

Hypercholesterolaemia | Small molecule | Cardiovascular |Organon & Co.|Last Updated: Aug 15, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment1,496

FDA Designations

No designations recorded

Clinical trial landscape

MK-0653, ezetimibe · 1 trial · 2 indications

Phase 3 1
NCT00328523TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)Hypercholesterolaemia
COMPLETED1,496 Analytics
PHASE3COMPLETED
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
HypercholesterolaemiaUnlock trial analytics

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 to 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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Frequently asked questions about MK-0653, ezetimibe

What is MK-0653 used for?

MK-0653, also known as ezetimibe, is used for hypercholesterolemia, including conditions like mixed hyperlipidemia and elevated cholesterol with coronary heart disease. It is being developed for lipid metabolism disorders and is in Phase 3 clinical trials.

What does MK-0653 target?

MK-0653 targets cholesterol absorption in the intestine. It is a small molecule that inhibits the absorption of cholesterol from the diet, thereby lowering blood cholesterol levels. This mechanism is relevant for treating hypercholesterolemia and related lipid disorders.

Who makes MK-0653?

MK-0653 is being developed by Organon & Co., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol OGN. The company is conducting Phase 3 clinical trials for this drug.

What phase is MK-0653 in?

MK-0653 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. All nine clinical trials for MK-0653 have been completed, with no active trials currently ongoing.

What clinical trials is MK-0653 in?

MK-0653 has been studied in several Phase 3 clinical trials, including NCT00092560, NCT00092573, NCT00092599, and NCT00092612. These trials enrolled patients with hypercholesterolemia, hypertriglyceridemia, and coronary heart disease, with a total enrollment of over 6,000 participants.

Is MK-0653 the same as ezetimibe?

Yes, MK-0653 is also known as ezetimibe. This alternative name is used in clinical trial titles and medical literature. Ezetimibe is the generic name for this cholesterol-lowering medication.