Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.

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Detailed Description

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Conditions

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Hypercholesterolemia, Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Simvastatin 40 mg first, then placebo

Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

40 mg once daily for 2 weeks

Placebo

Intervention Type DRUG

Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Placebo first, then simvastatin 40 mg once daily

Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks

Group Type PLACEBO_COMPARATOR

Simvastatin

Intervention Type DRUG

40 mg once daily for 2 weeks

Placebo

Intervention Type DRUG

Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Interventions

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Simvastatin

40 mg once daily for 2 weeks

Intervention Type DRUG

Placebo

Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Zocor

Eligibility Criteria

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Inclusion Criteria

* Participant is a Caucasian (including Hispanic) male
* Participant has a maximum waist size of 40 inches
* Participant does not currently use any lipid-altering medications
* Participant is in good health other than the diagnosis of dyslipidemia

Exclusion Criteria

* Participant has had stomach ulcers within the last 3 months
* Participant has had a heart attack in the last 6 months or has angina
* Participant has chronic heart failure
* Participant has a history of stroke, seizures, or major neurological disorder
* Participant has a history of cancer
* Participant has a gastrointestinal condition that affects bowel movements
* Participant has type 1 or 2 diabetes

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No