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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia, Mixed Dyslipidemia

In brief

The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.

Key facts

Study ID

NCT00639158

Run by

Abbott

People needed

543

Starts

2008-02-01

Last updated by the study team

2011-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to < 400 mg/dL; HDL-C < 40 mg/dL for males, < 50 mg/dL for females; LDL-C, > or = to 130 mg/dL).
• Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.

You may not qualify if…

• Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.
• 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.

Where it is running

• Study site — Columbiana, Alabama, United States
• Study site — Hueytown, Alabama, United States
• Study site — Ozark, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Carmichael, California, United States
• Study site — Concord, California, United States
• Study site — Long Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Norwalk, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Ana, California, United States
• Study site — Tustin, California, United States
• Study site — West Hills, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Clearwater, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Holly Hill, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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