A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00652301 |
Recruitment Status :
Completed
First Posted : April 3, 2008
Last Update Posted : March 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholesterol | Drug: ezetimibe Drug: Comparator: Placebo (unspecified) Drug: simvastatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Diagnostic |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol |
Study Start Date : | July 2003 |
Actual Primary Completion Date : | April 2004 |
Actual Study Completion Date : | April 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
ezetimibe 10 mg tablet plus simvastatin 20 mg tablet
|
Drug: ezetimibe
ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
Other Name: MK0653 Drug: simvastatin simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
Other Name: MK0733 |
Active Comparator: 2
ezetimibe 10 mg tablet
|
Drug: ezetimibe
ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
Other Name: MK0653 Drug: Comparator: Placebo (unspecified) matching placebo tablet. Duration of Treatment 31 Weeks. |
Active Comparator: 3
simvastatin 20 mg tablet
|
Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks. Drug: simvastatin simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
Other Name: MK0733 |
Placebo Comparator: 4
matching placebo
|
Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks. |
- reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. [ Time Frame: Based on 7 week treatment periods. ]
- To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. [ Time Frame: Based on 7 week treatment periods. ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy males between the ages of 18-55 with LDL More than 130, but less than 180
Exclusion Criteria:
- Individuals with drug or substance abuse
- Individuals with poor mental function
- Individuals having more than 14 alcoholic drinks a week
- Individuals that have been treated with any other investigational drug in the last 30 days

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): NCT00652301
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00652301 |
Other Study ID Numbers: |
0653-050 MK0653-050 2007_559 |
First Posted: | April 3, 2008 Key Record Dates |
Last Update Posted: | March 10, 2017 |
Last Verified: | March 2017 |
Simvastatin Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |