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

Sponsor:

Collaborator:

Schering-Plough

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Condition or disease	Intervention/treatment	Phase
Cholesterol	Drug: ezetimibe Drug: Comparator: Placebo (unspecified) Drug: simvastatin	Phase 3

Detailed Description:

Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know Cholesterol Medicines

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. [ Time Frame: Based on 7 week treatment periods. ]

Secondary Outcome Measures :

To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. [ Time Frame: Based on 7 week treatment periods. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Schering-Plough

Investigators

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Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Additional Information:

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Study Data/Documents: CSR Synopsis This link exits the ClinicalTrials.gov site

Publications of Results:

Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lütjohann D. Changes in cholesterol absorption and cholesterol synthesis caused by ezetimibe and/or simvastatin in men. J Lipid Res. 2009 Oct;50(10):2117-23. doi: 10.1194/jlr.P900004-JLR200. Epub 2009 Apr 20.

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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

Additional relevant MeSH terms:

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Simvastatin Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites	Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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