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Comparator: Placebo to ezetimibe/simvastatin
Ezetimibe/simvastatin is a combination that reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin).
Ezetimibe/simvastatin is a combination that reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin). Used for Hypercholesterolemia and mixed dyslipidemia.
At a glance
| Generic name | Comparator: Placebo to ezetimibe/simvastatin |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Combination lipid-lowering agent (ezetimibe + statin) |
| Target | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Ezetimibe selectively inhibits the Niemann-Pick C1-Like 1 (NPC1L1) transporter in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Simvastatin is an HMG-CoA reductase inhibitor that decreases de novo cholesterol synthesis in the liver. Together, they provide complementary mechanisms to lower LDL cholesterol and total cholesterol levels.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
Common side effects
- Elevated liver transaminases
- Myalgia
- Headache
- Abdominal pain
- Diarrhea
Key clinical trials
- 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) (PHASE3)
- A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED) (PHASE3)
- Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED) (PHASE3)
- Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801) (PHASE3)
- Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED) (PHASE3)
- An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED) (PHASE3)
- A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED) (PHASE3)
- To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
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