Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-24

Study Completion Date

2010-08-06

Brief Summary

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This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.

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Detailed Description

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Conditions

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Mixed Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

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MK-0524A

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Other Intervention Names

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Lipitor Zocor

Eligibility Criteria

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Inclusion Criteria

* Participant 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and 190 mg/dL and Triglycerides between 150 and 500 mg/dL

Exclusion Criteria

* Pregnant or lactating women, or women intending to become pregnant
* Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)
* Human immunodeficiency virus (HIV) positive
* Any of the following within the past 3 months: heart attack, stoke, heart bypass surgery, unstable angina, angioplasty
* Active or chronic liver disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No