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

Study Identifier
M10-275
CT.gov Identifier
NCT00639158
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dyslipidemia
  • Cardiovascular Disease
    • Study Drug
  • ABT-335
  • placebo
  • atorvastatin
  • ezetimibe
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - 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.
    Exclusion Criteria:
    - 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.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Birmingham, Alabama, United States, 35209
    Status
    Not applicable
    Location
    Columbiana, Alabama, United States, 35051
    Status
    Not applicable
    Location
    Hueytown, Alabama, United States, 35023
    Status
    Not applicable
    Location
    Ozark, Alabama, United States, 36360
    Status
    Not applicable
    Location
    Tuscaloosa, Alabama, United States, 35406
    Status
    Not applicable
    Location
    Sierra Vista, Arizona, United States, 85635
    Status
    Not applicable
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