A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia

Condition(s) targeted: Hypercholesterolemia

Intervention: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg (Drug); Comparator: rosuvastatin 10 mg (Drug); Comparator: rosuvastatin 10 mg + ezetimibe 10 mg (Drug); Comparator: rosuvastatin 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

A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in patients treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

Official title: A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: evaluate the LDL-C lowering efficacy

Secondary outcome:

To evaluate the LDL-C lowering efficacy of the addition of ezetimibe (10 mg) to rosuvastatin 5 mg compared with rosuvastatin 10 mg

To evaluate the LDL-C lowering efficacy of the additional of ezetimibe (10 mg) to rosuvastatin 10 mg compared with rosuvastatin 20 mg

The percentage of patients treated with rosuvastatin 5 mg or 10 mg alone achieving LDL-C levels recommended by NCEP/ATP III either by adding ezetimibe or doubling rosuvastatin dose

To assess the lipid, lipoprotein, apolipoprotein and high-sensitivity C-reactive protein (hs-CRP) altering effects

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

Criteria:

Inclusion Criteria:

- Patient is currently taking a stable dose of lipid lowering agent(s) (if applicable)

or is statin naive

- Patient is at least moderate high risk for CHD

- Patient is willing to maintain TLC/ADA diet

Exclusion Criteria:

- Patient weighs less than 100 lbs (45 kg)

- Patient has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any

components of these medications

- If female, patient is pregnant or breastfeeding

- Patient consumes more than 2 alcoholic beverages per day

- Patient has been in a clinical trial within the last 30 days

- Patient has heart problems such as CHF, unstable angina or heart attack

- Patient has type 1 or 2 diabetes and has changed their medication in the last 2

months

- Patient has liver disease. Patient is HIV positive

- Patient has a history of drug or alcohol abuse in the last year

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

Merck Sharp & Dohme, Glostrup 2600, Denmark; Recruiting
Christina Wengel, Phone: 45-43-28-77-90

MSD Finland Oy, Espoo 2151, Finland; Recruiting
Eero Helve, Phone: 358-9-804-65280

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

MSD Polska Sp. z o.o. Dzial Medyczny, Warszawa 00-867, Poland; Recruiting
Adam Czernik, Phone: 48 22 549-51-39

Call for Information, Manati 00674, Puerto Rico; Recruiting

Call for Information, Huntington Beach, California 92648, United States; Recruiting

Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400

Call for Information, Oviedo, Florida 32765, United States; Recruiting

Call for Information, Chicago, Illinois 60610-4377, United States; Recruiting

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

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

Call for Information, South Portland, Maine 04106, United States; Recruiting

Call for Information, Baltimore, Maryland 21209, United States; Recruiting

Call for Information, Sewell, New Jersey 08080, United States; Recruiting

Call for Information, Winston-Salem, North Carolina 27103-3914, United States; Recruiting

Call for Information, Oklahoma City, Oklahoma 73120, United States; Recruiting

Call for Information, Uniontown, Pennsylvania 15401, United States; Recruiting

Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605

Call for Information, Dallas, Texas 75231, United States; Recruiting

Call for Information, Layton, Utah 84041, United States; Recruiting

Call for Information, Richmond, Virginia 23249-0000, United States; Recruiting

Call for Information, Madison, Wisconsin 53719, United States; Recruiting

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Starting date: November 2008
Ending date: July 2010
Last updated: October 19, 2009