Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00166504 |
Recruitment Status :
Completed
First Posted : September 14, 2005
Results First Posted : November 5, 2008
Last Update Posted : February 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: ezetimibe (+) simvastatin Drug: atorvastatin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 203 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Vytorin
Ezetimibe 10 mg/Simvastatin 20 mg
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Drug: ezetimibe (+) simvastatin
simvastatin/ezetimibe 10/20 mg
Other Names:
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Active Comparator: Atorvastatin
Atorvastatin 10 mg
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Drug: atorvastatin
atorvastatin 10 mg
Other Name: Lipitor® |
- LDL-C Lowering Efficacy [ Time Frame: 6 weeks ]LDL-C = low density lipoprotein cholesterol, measured in mg/dl.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of hypercholesterolemia
- LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
- National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline
Exclusion Criteria:
- Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166504
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Responsible Party: | Organon and Co |
ClinicalTrials.gov Identifier: | NCT00166504 |
Other Study ID Numbers: |
0653A-092 MK0653A-092 2005_070 |
First Posted: | September 14, 2005 Key Record Dates |
Results First Posted: | November 5, 2008 |
Last Update Posted: | February 22, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Simvastatin Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |