Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.

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Detailed Description

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Conditions

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Cardiovascular Disorder Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ezetimibe/simvastatin

Group Type EXPERIMENTAL

ezetimibe (+) simvastatin

Intervention Type DRUG

ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.

atorvastatin 10 mg or simvastatin 20 mg

Intervention Type DRUG

All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.

Doubling statin dose

Group Type ACTIVE_COMPARATOR

simvastatin 40 mg or atorvastatin 20 mg

Intervention Type DRUG

simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.

atorvastatin 10 mg or simvastatin 20 mg

Intervention Type DRUG

All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.

Rosuvastatin

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

rosuvastatin 10 mg tablets, taken once daily for six weeks.

atorvastatin 10 mg or simvastatin 20 mg

Intervention Type DRUG

All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.

Interventions

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ezetimibe (+) simvastatin

ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.

Intervention Type DRUG

simvastatin 40 mg or atorvastatin 20 mg

simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.

Intervention Type DRUG

Rosuvastatin

rosuvastatin 10 mg tablets, taken once daily for six weeks.

Intervention Type DRUG

atorvastatin 10 mg or simvastatin 20 mg

All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.

Intervention Type DRUG

Other Intervention Names

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Vytorin Lipitor, Zocor Crestor Lipitor, Zocor

Eligibility Criteria

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Inclusion Criteria

* Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin
* Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study
* Patient is willing to remain abstinent or use birth control for the duration of the study
* Patient has Diabetes Mellitus with cardiovascular disease

Exclusion Criteria

* Patient has sensitivity to certain common statin drugs
* Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design
* Patient consumes more than 2 alcoholic drinks per day
* Patient is pregnant or breast-feeding
* Patient has been treated with other investigational drugs within 30 days of first visit
* Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin
* Patient has congestive heart failure
* Patient has uncontrolled high blood pressure
* Patient has kidney disease
* Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins
* Patient has diabetes mellitus that is not well controlled
* Patient is human immunodeficiency virus (HIV) positive
* Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4)
* Patient is currently taking therapies that would increase the risk of muscle weakness
* Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1
* Patient is currently taking psyllium or other fiber-based laxatives

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No