Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00862251
First received: March 12, 2009
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disorder Diabetes Mellitus |
Drug: ezetimibe (+) simvastatin Drug: simvastatin 40 mg or atorvastatin 20 mg Drug: Rosuvastatin Drug: atorvastatin 10 mg or simvastatin 20 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Simvastatin
Atorvastatin calcium
Rosuvastatin calcium
Ezetimibe
Rosuvastatin
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- 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). [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Triglycerides [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in LDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in TC/HDL-C Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Non-HDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Apo B/Apo A-I Ratio [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
| Enrollment: | 808 |
| Study Start Date: | April 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ezetimibe/simvastatin |
Drug: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
Other Name: Vytorin
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.
Other Name: Lipitor, Zocor
|
| Active Comparator: Doubling statin dose |
Drug: simvastatin 40 mg or atorvastatin 20 mg
simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
Other Name: Lipitor, Zocor
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.
Other Name: Lipitor, Zocor
|
| Active Comparator: Rosuvastatin |
Drug: Rosuvastatin
rosuvastatin 10 mg tablets, taken once daily for six weeks.
Other Name: Crestor
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.
Other Name: Lipitor, Zocor
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00862251 History of Changes |
| Other Study ID Numbers: | MK-0653A-133, 2009_559 |
| Study First Received: | March 12, 2009 |
| Results First Received: | February 23, 2012 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
cardiovascular disorder |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Simvastatin Atorvastatin Rosuvastatin Ezetimibe |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013