Eze/Simva Switch Study in Diabetics (0653A-807)
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ClinicalTrials.gov Identifier: NCT00541697 |
Recruitment Status :
Completed
First Posted : October 10, 2007
Last Update Posted : April 7, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 648 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes. |
Actual Study Start Date : | January 19, 2005 |
Actual Primary Completion Date : | September 28, 2005 |
Actual Study Completion Date : | October 14, 2005 |

- Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment [ Time Frame: 6 Weeks ]
- Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment [ Time Frame: 6 Weeks ]

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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:
- Currently being treated with Atorvastatin 10 mg for at least 6 weeks
- Have Type 2 Diabetes
- Weight must be stable for more than 6 weeks before entering the study
Exclusion Criteria:
- Consume more than 14 alcoholic drinks per week.
- Pregnant or lactating
- Have taken another investigation drug within 3 months of starting this study
- History of congestive heart failure, heart attack, coronary artery bypass surgery
- Uncontrolled high blood pressure
- HIV positive
- History of cancer in the last 5 years

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): NCT00541697
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00541697 |
Obsolete Identifiers: | NCT00093106 |
Other Study ID Numbers: |
0653A-807 MK0653A-807 2007_645 |
First Posted: | October 10, 2007 Key Record Dates |
Last Update Posted: | April 7, 2017 |
Last Verified: | April 2017 |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Atorvastatin Simvastatin Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |