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A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia; Dyslipidemia

Intervention: ABT-335 and Rosuvastatin Combination (Other); ABT-335 (Drug); rosuvastatin calcium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

Clinical Details

Official title: A 12-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia

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

Primary outcome:

Triglycerides

HDL-C

Direct LDL-C

Secondary outcome:

Non-HDL-C and VLDL

Total Cholesterol

Lipoprotein apoB

High sensitivity C-reactive protein (hsCRP)

Eligibility

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

Criteria:

Inclusion Criteria:

- Adult male and female subjects who voluntarily sign the informed consent and meet the

lipid inclusion criteria for dyslipidemia.

- Subject is >= 18 years of age at the time of the Pre-screening Visit.

- Subjects must agree to utilize adequate birth control methods and to adhere to the AHA

diet.

Exclusion Criteria:

- Subjects with unstable medical conditions, medical conditions considered inappropriate

in a clinical trial, or subjects who are taking excluded concomitant medications are not allowed in the study.

Locations and Contacts

Huntsville, Alabama 35801, United States

Northport, Alabama 35476, United States

Ozark, Alabama 36360, United States

Birmingham, Alabama 35205, United States

Birmingham, Alabama 35235, United States

Huntsville, Alabama 35802, United States

Birmingham, Alabama 35209, United States

Gilbert, Arizona 85296, United States

Scottsdale, Arizona 85251, United States

Chandler, Arizona 85225, United States

Little Rock, Arkansas 72204, United States

Fair Oaks, California 95628, United States

Sacramento, California 95825, United States

Lincoln, California 95648, United States

Santa Ana, California 92701, United States

Encinitas, California 92024, United States

Long Beach, California 90806, United States

Fresno, California 93703, United States

Fresno, California 93710, United States

Concord, California 94520, United States

Los Angeles, California 90057, United States

Norwalk, California 90650, United States

San Diego, California 92128, United States

Chula Vista, California 91911, United States

West Hills, California 91307, United States

Colorado Springs, Colorado 80909, United States

Denver, Colorado 80218, United States

Waterbury, Connecticut 06708, United States

Fort Lauderdale, Florida 33308, United States

Coral Gables, Florida 33134, United States

Hollywood, Florida 33021, United States

Kissimmee, Florida 34741, United States

Miami, Florida 33173, United States

New Smyrna Beach, Florida 32168, United States

Ocala, Florida 34471, United States

Holly Hill, Florida 32117, United States

New Port Richey, Florida 34652, United States

Melbourne, Florida 32935, United States

Jacksonville, Florida 32216, United States

West Palm Beach, Florida 33401, United States

Sarasota, Florida 34233, United States

Jacksonville, Florida 32259, United States

West Palm Beach, Florida 33407, United States

Winter Haven, Florida 33880, United States

Ormond Beach, Florida 32174, United States

Largo, Florida 33773, United States

Sarasota, Florida 34239, United States

Pensacola, Florida 32514, United States

Jupiter, Florida 33458, United States

Orlando, Florida 32806, United States

Roswell, Georgia 30076, United States

Dunwoody, Georgia 30338, United States

Woodstock, Georgia 30189, United States

Suwanee, Georgia 30024, United States

Roswell, Georgia 30075, United States

Decatur, Georgia 30033, United States

Blue Ridge, Georgia 30513, United States

Arlington Heights, Illinois 60004, United States

Chicago, Illinois 60610, United States

Peoria, Illinois 61602, United States

Indianapolis, Indiana 46260, United States

Lafayette, Indiana 47904, United States

Newburgh, Indiana 47630, United States

Evansville, Indiana 47714, United States

Avon, Indiana 46123, United States

Iowa City, Iowa 52242, United States

Wichita, Kansas 67207, United States

Wichita, Kansas 67203, United States

Arkansas City, Kansas 67005, United States

Overland Park, Kansas 66202, United States

Louisville, Kentucky 40213, United States

Mt. Sterling, Kentucky 40353, United States

Slidell, Louisiana 70458, United States

Kenner, Louisiana 70065, United States

Scarborough, Maine 04074, United States

Auburn, Maine 04210, United States

Baltimore, Maryland 21209, United States

Springfield, Massachusetts 01103, United States

Haverhill, Massachusetts 01830, United States

Ann Arbor, Michigan 48106, United States

Portage, Michigan 49024, United States

Brooklyn Center, Minnesota 55430, United States

Olive Branch, Mississippi 38654, United States

Jackson, Mississippi 39202, United States

Tupelo, Mississippi 38803, United States

St. Peters, Missouri 63376, United States

Kansas City, Missouri 64114, United States

Billings, Montana 59101, United States

Missoula, Montana 59808, United States

Las Vegas, Nevada 89102, United States

Las Vegas, Nevada 89146, United States

Las Vegas, Nevada 89123, United States

Concord, New Hampshire 03301, United States

Elizabeth, New Jersey 07202, United States

Trenton, New Jersey 08611, United States

Toms River, New Jersey 08755, United States

South Bound Brook, New Jersey 08880, United States

Albuquerque, New Mexico 87108, United States

Syracuse, New York 13202, United States

Rochester, New York 14609, United States

Bronxville, New York 10506, United States

Williamsville, New York 14221, United States

New York, New York 10021, United States

Morehead City, North Carolina 28557, United States

Asheville, North Carolina 28803, United States

Raleigh, North Carolina 27609, United States

Hickory, North Carolina 28601, United States

Winston-Salem, North Carolina 27103, United States

Charlotte, North Carolina 28209, United States

Charlotte, North Carolina 28277, United States

Salisbury, North Carolina 28144, United States

Statesville, North Carolina 28677, United States

Cincinnati, Ohio 45219, United States

Warren, Ohio 44483, United States

Cincinnati, Ohio 45229, United States

Cincinnati, Ohio 45246, United States

Mogadore, Ohio 44260, United States

Sandusky, Ohio 44089, United States

Columbus, Ohio 43212, United States

Oklahoma City, Oklahoma 73103, United States

Oklahoma City, Oklahoma 73112, United States

Tulsa, Oklahoma 74136, United States

Tulsa, Oklahoma 74104, United States

Medford, Oregon 97504, United States

Melrose Park, Pennsylvania 19027, United States

Philadelphia, Pennsylvania 19114, United States

Lansdale, Pennsylvania 19046, United States

Warminster, Pennsylvania 18974, United States

Penndel, Pennsylvania 19047, United States

Carlisle, Pennsylvania 17015, United States

Newtown, Pennsylvania 18940, United States

Jersey Shore, Pennsylvania 17740, United States

Philadelphia, Pennsylvania 19115, United States

Feasterville, Pennsylvania 19053, United States

Philadelphia, Pennsylvania 19152, United States

Harleysville, Pennsylvania 19438-1513, United States

Downingtown, Pennsylvania 19335, United States

Summerville, South Carolina 29485, United States

Simpsonville, South Carolina 29681, United States

Greer, South Carolina 29651, United States

Mt. Pleasant, South Carolina 29464, United States

Moncks Corner, South Carolina 29461, United States

Charleston, South Carolina 29407, United States

Sioux Falls, South Dakota 57104, United States

Nashville, Tennessee 37205, United States

Jackson, Tennessee 38305, United States

Johnson City, Tennessee 37601, United States

San Antonio, Texas 78229, United States

San Antonio, Texas 78224, United States

Arlington, Texas 76012, United States

San Antonio, Texas 78205, United States

Temple, Texas 76502, United States

Houston, Texas 77030, United States

Richmond, Virginia 23294, United States

Richmond, Virginia 23226, United States

Falls Church, Virginia 22044, United States

Lakewood, Washington 98499, United States

Madison, Wisconsin 53719, United States

Additional Information

Starting date: April 2007
Last updated: June 16, 2008

Page last updated: June 20, 2008

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