Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for CHD

Condition(s) targeted: Hypercholesterolemia

Intervention: ezetimibe (Drug); Comparator: atorvastatin calcium (Drug); Comparator: Placebo (unspecified) (Drug); Comparator: Placebo (unspecified) (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 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.

Official title: A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD

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

Primary outcome: LDL levels

Secondary outcome:

LDL levels

Percent of patients reaching pre-specified LDL levels

Other lipid parameters

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is age 65 or older

- Patient is willing to maintain cholesterol lowering diet

- Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending

on their CHD risk category

Exclusion Criteria:

- A condition which, in the opinion of the investigator, would pose a risk to the

patient or interfere with participation in the study

- Patient is unlikely to be compliant in taking study medication

- Patient with chronic or unstable medical condition

- Patient is taking unstable doses of medication

- Patient drinks more than 2 alcoholic drinks per day

- Patient has elevations in certain laboratory values (CK, AST, ALT)

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

Call for Information, Huntsville, Alabama 35801, United States; Recruiting

Call for Information, Birmingham, Alabama 35294-007, United States; Recruiting

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

Call for Information, Phoenix, Arizona 85014, United States; Recruiting

Call for Information, Vista, California 92083-0000, United States; Recruiting

Call for Information, Santa Ana, California 92705, United States; Recruiting

Call for Information, San Diego, California 92120-0000, United States; Recruiting

Call for Information, San Diego, California 92103-8411, United States; Recruiting

Call for Information, Sacramento, California 95831, United States; Recruiting

Call for Information, Fountain Valley, California 92708, United States; Recruiting

Call for Information, Concord, California 94520, United States; Recruiting

Call for Information, Denver, Colorado 80218, United States; Recruiting

Call for Information, Aurora, Colorado 80012, United States; Recruiting

Call for Information, Stamford, Connecticut 06905-0000, United States; Recruiting

Call for Information, Washington, District of Columbia 20037, United States; Recruiting

Call for Information, West Palm Beach, Florida 33401-0000, United States; Recruiting

Call for Information, Port Orange, Florida 32127, United States; Recruiting

Call for Information, Pembroke Pines, Florida 33024-0000, United States; Recruiting

Call for Information, Ocala, Florida 34471, United States; Recruiting

Call for Information, Longwood, Florida 32779, United States; Recruiting

Call for Information, Jupiter, Florida 33458, United States; Recruiting

Call for Information, Jacksonville, Florida 32205, United States; Recruiting

Call for Information, Fort Lauderdale, Florida 33308-0000, United States; Recruiting

Call for Information, Clearwater, Florida 33761-0000, United States; Recruiting

Call for Information, Aventura, Florida 33180, United States; Recruiting

Call for Information, Dawsonville, Georgia 30534, United States; Recruiting

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

Call for Information, Atlanta, Georgia 30303, United States; Recruiting

Call for Information, Rockford, Illinois 61108, United States; Recruiting

Call for Information, Normal, Illinois 61761, United States; Recruiting

Call for Information, Wichita, Kansas 67207-0000, United States; Recruiting

Call for Information, Owensboro, Kentucky 42303, United States; Recruiting

Call for Information, Munfordville, Kentucky 42765, United States; Recruiting

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

Call for Information, Lexington, Kentucky 40504, United States; Recruiting

Call for Information, Elizabethtown, Kentucky 42701, United States; Recruiting

Call for Information, Scarborough, Maine 04074, United States; Recruiting

Call for Information, Baltimore, Maryland 21287, United States; Recruiting

Call for Information, Baltimore, Maryland 21204, United States; Recruiting

Call for Information, Waltham, Massachusetts 02453, United States; Recruiting

Call for Information, Saint Paul, Minnesota 55102-0000, United States; Recruiting

Call for Information, Chesterfield, Missouri 63017, United States; Recruiting

Call for Information, Concord, New Hampshire 03301, United States; Recruiting

Call for Information, Edison, New Jersey 08817, United States; Recruiting

Call for Information, Williamsville, New York 14221, United States; Recruiting

Call for Information, Syracuse, New York 13202-0000, United States; Recruiting

Call for Information, Rochester, New York 14609, United States; Recruiting

Call for Information, Mineola, New York 11501, United States; Recruiting

Call for Information, Winston-Salem, North Carolina 27157, United States; Recruiting

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

Call for Information, Wilmington, North Carolina 28401, United States; Recruiting

Call for Information, Statesville, North Carolina 28677, United States; Recruiting

Call for Information, Elizabeth City, North Carolina 27909, United States; Recruiting

Call for Information, Charlotte, North Carolina 28209, United States; Recruiting

Call for Information, Mason, Ohio 45040, United States; Recruiting

Call for Information, Marion, Ohio 43302, United States; Recruiting

Call for Information, Cincinnati, Ohio 45227, United States; Recruiting

Call for Information, Oklahoma City, Oklahoma 73103-0000, United States; Recruiting

Call for Information, Bartlesville, Oklahoma 74006, United States; Recruiting

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

Call for Information, Philadelphia, Pennsylvania 19152, United States; Recruiting

Call for Information, Fleetwood, Pennsylvania 19522, United States; Recruiting

Call for Information, Beaver, Pennsylvania 15009, United States; Recruiting

Call for Information, Charleston, South Carolina 29412, United States; Recruiting

Call for Information, Bristol, Tennessee 37620-0000, United States; Recruiting

Call for Information, San Antonio, Texas 78229, United States; Recruiting

Call for Information, Houston, Texas 77030, United States; Recruiting

Call for Information, Fort Worth, Texas 76117, United States; Recruiting

Call for Information, Dallas, Texas 75235, United States; Recruiting

Call for Information, Beaumont, Texas 77702, United States; Recruiting

Call for Information, Salt Lake City, Utah 84108, United States; Recruiting

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

Call for Information, Petersburg, Virginia 23803, United States; Recruiting

Call for Information, Tacoma, Washington 98405, United States; Recruiting

Call for Information, Gig Harbor, Washington 98335, United States; Recruiting

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: January 2007
Last updated: August 6, 2008