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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862251
• Other study ID #: 0653A-133
• Secondary ID: 2009_559
• Status: Completed
• Phase: Phase 3
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 808
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Disorder
• Diabetes Mellitus

Intervention

Drug:
• ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
• simvastatin 40 mg or atorvastatin 20 mg
simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
• Rosuvastatin
rosuvastatin 10 mg tablets, taken once daily for six weeks.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Baseline and Week 6
Secondary	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		Baseline and Week 6
Secondary	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		Baseline and Week 6
Secondary	Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin		Baseline and Week 6
Secondary	Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)		Week 6
Secondary	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)		Week 6
Secondary	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)		Week 6
Secondary	Percent Change From Baseline in Total Cholesterol (TC)		Baseline and Week 6
Secondary	Percent Change From Baseline in Triglycerides		Baseline and Week 6
Secondary	Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)		Baseline and Week 6
Secondary	Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)		Baseline and Week 6
Secondary	Percent Change From Baseline in LDL-C/HDL-C Ratio		Baseline and Week 6
Secondary	Percent Change From Baseline in TC/HDL-C Ratio		Baseline and Week 6
Secondary	Percent Change From Baseline in Non-HDL-C/HDL-C Ratio		Baseline and Week 6
Secondary	Percent Change From Baseline in Apolipoprotein B (Apo B)		Baseline and Week 6
Secondary	Percent Change From Baseline Apolipoprotein A-I (Apo A-I)		Baseline and Week 6
Secondary	Percent Change From Baseline in Apo B/Apo A-I Ratio		Baseline and Week 6
Secondary	Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)		Baseline and Week 6