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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR VYTORIN

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Clinical Trials for Vytorin

Trial ID Title Status Sponsor Phase Summary
NCT00166504 Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.
NCT00202878 IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103) Completed Merck Sharp & Dohme Corp. Phase 3 This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.
NCT00395603 Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122) Terminated Merck Sharp & Dohme Corp. Phase 3 To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.
NCT00413972 Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420) Completed Schering-Plough Phase 3 This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 consecutive weeks in subjects with primary hypercholesterolemia (LDL-C >3.64 mmol/L [140 mg/dL]). The efficacy of daily Vytorin versus placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily Vytorin versus placebo with respect to change in the concentrations of total cholesterol, triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be assessed.
NCT00413972 Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420) Completed Merck Sharp & Dohme Corp. Phase 3 This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 consecutive weeks in subjects with primary hypercholesterolemia (LDL-C >3.64 mmol/L [140 mg/dL]). The efficacy of daily Vytorin versus placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily Vytorin versus placebo with respect to change in the concentrations of total cholesterol, triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be assessed.
NCT00442897 Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Vytorin

Condition Name

Condition Name for Vytorin
Intervention Trials
Hypercholesterolemia 14
Hyperlipidemia 4
Diabetes Mellitus 3
Cardiovascular Diseases 3
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Condition MeSH

Condition MeSH for Vytorin
Intervention Trials
Hypercholesterolemia 14
Diabetes Mellitus 5
Cardiovascular Diseases 5
Dyslipidemias 4
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Clinical Trial Locations for Vytorin

Trials by Country

Trials by Country for Vytorin
Location Trials
United States 9
Korea, Republic of 4
Brazil 3
United Kingdom 1
Taiwan 1
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Trials by US State

Trials by US State for Vytorin
Location Trials
New York 2
Michigan 1
California 1
Florida 1
Texas 1
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Clinical Trial Progress for Vytorin

Clinical Trial Phase

Clinical Trial Phase for Vytorin
Clinical Trial Phase Trials
Phase 4 15
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Vytorin
Clinical Trial Phase Trials
Completed 29
Unknown status 3
Withdrawn 2
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Clinical Trial Sponsors for Vytorin

Sponsor Name

Sponsor Name for Vytorin
Sponsor Trials
Merck Sharp & Dohme Corp. 22
Gachon University Gil Medical Center 2
University of Sao Paulo 1
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Sponsor Type

Sponsor Type for Vytorin
Sponsor Trials
Industry 25
Other 20
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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US Army
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