Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
NCT ID: NCT00639158
Last Updated: 2011-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
543 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABT-335 + atorvastatin + ezetimibe
ABT-335
135 mg capsule, daily, 12 weeks
atorvastatin
40 mg, tablet, daily, 12 weeks
ezetimibe
10 mg capsule, daily, 12 weeks
Placebo + atorvastatin + ezetimibe
placebo
placebo capsule, daily, 12 weeks
atorvastatin
40 mg, tablet, daily, 12 weeks
ezetimibe
10 mg capsule, daily, 12 weeks
Interventions
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ABT-335
135 mg capsule, daily, 12 weeks
placebo
placebo capsule, daily, 12 weeks
atorvastatin
40 mg, tablet, daily, 12 weeks
ezetimibe
10 mg capsule, daily, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.
Exclusion Criteria
* Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.
* Women who are pregnant or plan on becoming pregnant, or women who are lactating.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Birmingham, Alabama, United States
Columbiana, Alabama, United States
Hueytown, Alabama, United States
Ozark, Alabama, United States
Tuscaloosa, Alabama, United States
Sierra Vista, Arizona, United States
Hot Springs, Arkansas, United States
Carmichael, California, United States
Concord, California, United States
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Norwalk, California, United States
Roseville, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Tustin, California, United States
West Hills, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Holly Hill, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Longwood, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
New Smyrna Beach, Florida, United States
Ocala, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Roswell, Georgia, United States
Suwanee, Georgia, United States
Woodstock, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Evansville, Indiana, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Arkansas City, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Mount Sterling, Kentucky, United States
Slidell, Louisiana, United States
Baltimore, Maryland, United States
Oxon Hill, Maryland, United States
Brockton, Massachusetts, United States
Edina, Minnesota, United States
Olive Branch, Mississippi, United States
City of Saint Peters, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Elizabeth, New Jersey, United States
Hillsborough, New Jersey, United States
Trenton, New Jersey, United States
Johnson City, New York, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Mason, Ohio, United States
Mogadore, Ohio, United States
Warren, Ohio, United States
Tulsa, Oklahoma, United States
Hillsboro, Oregon, United States
Duncansville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Melrose Park, Pennsylvania, United States
Newtown, Pennsylvania, United States
Perkasie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Tipton, Pennsylvania, United States
Warminster, Pennsylvania, United States
Cumberland, Rhode Island, United States
Anderson, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Simpsonville, South Carolina, United States
Summerville, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66. doi: 10.1016/j.ahj.2010.06.045.
Other Identifiers
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M10-275
Identifier Type: -
Identifier Source: org_study_id
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