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

Condition(s) targeted: Cardiovascular Disorder; Diabetes Mellitus

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

Phase: Phase 3

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) vs rosuvastatin (10 mg) vs 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.

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 vs Switching to Rosuvastatin or Doubling the Statin Dose

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

Primary outcome: Percent reduction of LDL-C after switching to treatment with ezetimibe/simvastatin vs doubling the dose of statin (simvastatin or atorvastatin).

Secondary outcome: 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.

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 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.

Toll Free Number, Phone: 1-888-577-8839

Merck Sharp & Dohme Gmbh, Vienna 1220, Austria; Recruiting
Andras Festa, Phone: 43-1-26044-130

Merck Sharp & Dohme IDEA Inc., Sofia, Bulgaria; Recruiting
Aneta Sokolova, Phone: 359-2-963-1076

Merck Sharp & Dohme (I.A.) Corp., Santiago 6761641, Chile; Recruiting
Jorge Vinces, Phone: 51-1-411-5933

Merck Sharp & Dohme (I.A.) Corp., San Jose, Costa Rica; Recruiting
Patricia Salazar, Phone: 506-2210-0116

Merck Sharp & Dohme IDEA, Inc., Zagreb 10 010, Croatia; Recruiting
Goranka Glad Scherr, Phone: 385 1 66 44 336

Merck Sharp & Dohme Scientific Office, Cairo, Egypt; Recruiting
Sherif Canaan, Phone: 202-2417-2320

Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536

MSD Magyarorszag Kft., Budapest 1123, Hungary; Recruiting
Geza Szoverffy, Phone: 36-1 888 5325

Merck Sharp & Dohme (Italia) S.P.A., Roma 191, Italy; Recruiting
Gianfranco Botta, Phone: 39 06 36 191187

Merck Sharp & Dohme Idea Inc, Riga 1013, Latvia; Recruiting
Andrius Bacevicius, Phone: 370-5-2780-243

Merck Sharp & Dohme Lda, Paco D`arcos 2770-192, Portugal; Recruiting
Lai Hung Jen, Phone: 351-21-4465821

Call for Information, Tempe, Arizona 85282, United States; Recruiting

Call for Information, Tucson, Arizona 85741, United States; Recruiting

Merck Sharp & Dohme IDEA, Inc., Tallinn, Eesti 11415, Estonia; Recruiting
Andrius Bacevicius, Phone: 370-5-2780-243

Call for Information, Clearwater, Florida 33756, United States; Recruiting

Call for Information, Coral Gables, Florida 33134, United States; Recruiting

Call for Information, Atlanta, Georgia 30308, United States; Recruiting

Call for Information, Evansville, Indiana 47714, United States; Recruiting

Call for Information, Louisville, Kentucky 40213, United States; Recruiting

UAB Merck Sharp & Dohme, Vilnius, Lietuva, Lithuania; Recruiting
Andrius Bacevicius, Phone: 3705 2 780 243

Merck Sharp & Dohme, Peru S.R.L., Surquillo, Lima LIMA 34, Peru; Recruiting
Jorge Vinces, Phone: 511-411-5933

Call for Information, Frederick, Maryland 21702, United States; Recruiting

Call for Information, Berlin, New Jersey 08009, United States; Recruiting

Call for Information, Lake Jackson, Texas 77566, United States; Recruiting

Call for Information, Norfolk, Virginia 23502, United States; Recruiting

Call for Information, Richmond, Virginia 23294, United States; Recruiting

Starting date: April 2009
Last updated: August 12, 2010