Safety and Efficacy Study Comparing ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Abnormal Lipid (Fat) Levels in the Blood

Condition(s) targeted: Dyslipidemias; Coronary Heart Disease; Combined (Atherogenic) Dyslipidemia; Mixed Dyslipidemia

Intervention: ABT-335 (Drug); placebo (Drug); atorvastatin (Drug); ezetimibe (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Abbott

Overall contact:
Debra M. Schuerr, BS, Phone: 847-937-5748, Email: debra.m.schuerr@abbott.com

The primary purpose of this study is to test the effect and safety of using an investigational drug regimen containing three medications; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin and once daily ezetimibe to study the effects on patients with abnormal lipid (fat) levels in the blood.

Official title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Identify rate of change by measuring baseline levels of triglycerides at various study intervals

Identify rate of change by measuring baseline levels of HDL-C at various study intervals

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with mixed dyslipidemia.

Exclusion Criteria:

- Patients with certain chronic or unstable medical conditions.

- Patients with unstable dose of medications or receiving Coumadin, cyclosporine, or

certain other medications.

- Pregnant or lactating women, or women intending to become pregnant.

- Patients with diabetes mellitus that is poorly controlled.

Debra M. Schuerr, BS, Phone: 847-937-5748, Email: debra.m.schuerr@abbott.com

Birmingham, Alabama 35209, United States; Recruiting

Columbiana, Alabama 35051, United States; Recruiting

Hueytown, Alabama 35023, United States; Recruiting

Ozark, Alabama 36360, United States; Recruiting

Tuscaloosa, Alabama 35406, United States; Recruiting

Sierra Vista, Arizona 85635, United States; Recruiting

Hot Springs, Arkansas 71913, United States; Recruiting

Carmichael, California 95608, United States; Recruiting

Concord, California 94520, United States; Recruiting

Long Beach, California 90806, United States; Recruiting

Long Beach, California 90822, United States; Recruiting

Los Angeles, California 90057, United States; Recruiting

Norwalk, California 90650, United States; Recruiting

Roseville, California 95661, United States; Recruiting

Sacramento, California 95825, United States; Recruiting

Santa Ana, California 92701, United States; Recruiting

Tustin, California 92780, United States; Recruiting

West Hills, California 91307, United States; Recruiting

Colorado Springs, Colorado 80904, United States; Recruiting

Clearwater, Florida 33756, United States; Recruiting

Delray Beach, Florida 33484, United States; Recruiting

Fort Myers, Florida 33907, United States; Recruiting

Daytona Beach, Florida 32117, United States; Recruiting

Jacksonville, Florida 32259, United States; Recruiting

Jacksonville, Florida 32216, United States; Recruiting

Kissimmee, Florida 34741, United States; Recruiting

Longwood, Florida 32750, United States; Recruiting

Miami, Florida 33173, United States; Recruiting

New Port Richey, Florida 34652, United States; Recruiting

New Smyrna Beach, Florida 32168, United States; Recruiting

Ocala, Florida 34471, United States; Recruiting

Ormond Beach, Florida 32174, United States; Recruiting

Pembroke Pines, Florida 33002, United States; Recruiting

Sarasota, Florida 34233, United States; Recruiting

Tampa, Florida 33607, United States; Recruiting

Atlanta, Georgia 30342, United States; Recruiting

Augusta, Georgia 30904, United States; Recruiting

Roswell, Georgia 30076, United States; Recruiting

Suwanee, Georgia 30024, United States; Recruiting

Woodstock, Georgia 30189, United States; Recruiting

Boise, Idaho 83704, United States; Recruiting

Chicago, Illinois 60610, United States; Recruiting

Chicago, Illinois 60607, United States; Recruiting

Peoria, Illinois 61602, United States; Recruiting

Evansville, Indiana 47714, United States; Recruiting

Evansville, Indiana 47713, United States; Recruiting

Indianapolis, Indiana 46260, United States; Recruiting

Iowa City, Iowa 52242, United States; Recruiting

Arkansas City, Kansas 67005, United States; Recruiting

Overland Park, Kansas 66202, United States; Recruiting

Wichita, Kansas 67207, United States; Recruiting

Louisville, Kentucky 40213, United States; Recruiting

Mt. Sterling, Kentucky 40353, United States; Recruiting

Slidell, Louisiana 70458, United States; Recruiting

Baltimore, Maryland 21209, United States; Recruiting

Oxon Hill, Maryland 20745, United States; Recruiting

Brockton, Massachusetts 02301, United States; Recruiting

Edina, Minnesota 55435, United States; Recruiting

Olive Branch, Mississippi 38654, United States; Recruiting

St. Louis, Missouri 63141, United States; Recruiting

St. Peters, Missouri 63376, United States; Recruiting

Billings, Montana 59101, United States; Recruiting

Las Vegas, Nevada 89123, United States; Recruiting

Berlin, New Jersey 08844, United States; Recruiting

Elizabeth, New Jersey 07202, United States; Recruiting

Trenton, New Jersey 08611, United States; Recruiting

Johnson City, New York 13790, United States; Recruiting

Charlotte, North Carolina 28209, United States; Recruiting

Hickory, North Carolina 28601, United States; Recruiting

Salisbury, North Carolina 28144, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Recruiting

Statesville, North Carolina 25677, United States; Recruiting

Raleigh, North Carolina 27609, United States; Recruiting

Cincinnati, Ohio 45219, United States; Recruiting

Mason, Ohio 45040, United States; Recruiting

Mogadore, Ohio 44260, United States; Recruiting

Warren, Ohio 44483, United States; Recruiting

Tulsa, Oklahoma 74136, United States; Recruiting

Hillsboro, Oregon 97123, United States; Recruiting

Duncansville, Pennsylvania 16635, United States; Recruiting

Harleysville, Pennsylvania 19438, United States; Recruiting

Jersey Shore, Pennsylvania 17740, United States; Recruiting

Lansdale, Pennsylvania 19446, United States; Recruiting

Melrose Park, Pennsylvania 19027, United States; Recruiting

Perkasie, Pennsylvania 18944, United States; Recruiting

Philadelphia, Pennsylvania 19114, United States; Recruiting

Philadelphia, Pennsylvania 19152, United States; Recruiting

Pittsburgh, Pennsylvania 15216, United States; Recruiting

Sellersville, Pennsylvania 18960, United States; Recruiting

Tipton, Pennsylvania 16684, United States; Recruiting

Warminster, Pennsylvania 18974, United States; Recruiting

Cumberland, Rhode Island 02864, United States; Recruiting

Anderson, South Carolina 29621, United States; Recruiting

Greenville, South Carolina 29615, United States; Recruiting

Greer, South Carolina 29651, United States; Recruiting

Simpsonville, South Carolina 29681, United States; Recruiting

Summerville, South Carolina 29485, United States; Recruiting

Dallas, Texas 75230, United States; Recruiting

Fort Worth, Texas 76104, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Salt Lake City, Utah 84107, United States; Recruiting

West Jordan, Utah 84088, United States; Recruiting

Salt Lake City, Utah 84103, United States; Recruiting

Norfolk, Virginia 23502, United States; Recruiting

Richmond, Virginia 23294, United States; Recruiting

Virginia Beach, Virginia 23455, United States; Recruiting

Spokane, Washington 99216, United States; Recruiting

Madison, Wisconsin 53719, United States; Recruiting

Starting date: March 2008
Last updated: June 26, 2008