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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Disorder; Diabetes Mellitus

Intervention: ezetimibe (+) simvastatin (Drug); simvastatin 40 mg or atorvastatin 20 mg (Drug); Rosuvastatin (Drug); atorvastatin 10 mg or simvastatin 20 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

Official title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).

Secondary outcome:

In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin

In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin

Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin

Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)

In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)

In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)

Percent Change From Baseline in Total Cholesterol (TC)

Percent Change From Baseline in Triglycerides

Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Percent Change From Baseline in LDL-C/HDL-C Ratio

Percent Change From Baseline in TC/HDL-C Ratio

Percent Change From Baseline in Non-HDL-C/HDL-C Ratio

Percent Change From Baseline in Apolipoprotein B (Apo B)

Percent Change From Baseline Apolipoprotein A-I (Apo A-I)

Percent Change From Baseline in Apo B/Apo A-I Ratio

Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)

Eligibility

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: December 10, 2014

Page last updated: August 23, 2015

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