Ezetimibe/Simvastatin (MK0653A) vs Rosuvastatin Versus Doubling Statin Dose in Patients With Cardiovascular Disease and Diabetes Mellitus (0653A-133)(COMPLETED) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00862251

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 Diseases Diabetes Mellitus	Drug: ezetimibe (+) simvastatin Drug: Comparator: simvastatin 40 mg or atorvastatin 20 mg Drug: Comparator: rosuvastatin Drug: Comparator: atorvastatin 10 mg or simvastatin 20 mg	Phase III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Statins

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Rosuvastatin calcium Ezetimibe Rosuvastatin Vytorin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percent reduction of LDL-C after switching to treatment with ezetimibe/simvastatin vs doubling the dose of statin (simvastatin or atorvastatin). [ Time Frame: Six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In patients treated with simvastatin at baseline, percent reduction of LDL-C after switching to treatment with ezetimibe/simvastatin vs doubling the dose of simvastatin. [ Time Frame: Six weeks ] [ Designated as safety issue: No ]

Enrollment:	810
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: 1 ezetimibe/simvastatin	Drug: ezetimibe (+) simvastatin ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks. Other Name: Vytorin Drug: Comparator: 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: 2 Doubling statin dose.	Drug: Comparator: 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: Comparator: 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: 3 rosuvastatin 10 mg tablets	Drug: Comparator: rosuvastatin rosuvastatin 10 mg tablets, taken once daily for six weeks. Other Name: Crestor Drug: Comparator: 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 HIV positive
Patient is currently taking medications that inhibit 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862251

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00862251 History of Changes
Other Study ID Numbers:	2009_559, MK0653A-133
Study First Received:	March 12, 2009
Last Updated:	March 25, 2011
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 February 09, 2012