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A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

NCT ID: NCT00652301

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-04-30

Brief Summary

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

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Detailed Description

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

Conditions

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Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

ezetimibe 10 mg tablet plus simvastatin 20 mg tablet

Group Type EXPERIMENTAL

ezetimibe

Intervention Type DRUG

ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.

simvastatin

Intervention Type DRUG

simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.

2

ezetimibe 10 mg tablet

Group Type ACTIVE_COMPARATOR

ezetimibe

Intervention Type DRUG

ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.

Comparator: Placebo (unspecified)

Intervention Type DRUG

matching placebo tablet. Duration of Treatment 31 Weeks.

3

simvastatin 20 mg tablet

Group Type ACTIVE_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type DRUG

matching placebo tablet. Duration of Treatment 31 Weeks.

simvastatin

Intervention Type DRUG

simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.

4

matching placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type DRUG

matching placebo tablet. Duration of Treatment 31 Weeks.

Interventions

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ezetimibe

ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.

Intervention Type DRUG

Comparator: Placebo (unspecified)

matching placebo tablet. Duration of Treatment 31 Weeks.

Intervention Type DRUG

simvastatin

simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.

Intervention Type DRUG

Other Intervention Names

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MK0653 MK0733

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lutjohann 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.

Reference Type RESULT
PMID: 19380898 (View on PubMed)

Other Identifiers

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MK0653-050

Identifier Type: -

Identifier Source: secondary_id

2007_559

Identifier Type: -

Identifier Source: secondary_id

0653-050

Identifier Type: -

Identifier Source: org_study_id

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