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

• Median Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as safety issue: No ]
  [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
• Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
  [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100

• Identify rate of change by measuring baseline levels of triglycerides at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Identify rate of change by measuring baseline levels of HDL-C at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

• Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
  [(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100
• Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (final visit) ] [ Designated as safety issue: No ]
  [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100
• Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
  [(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100
• Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
  [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100
• Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
  [(Week 12 apoB minus baseline apoB)/baseline apoB] x 100
• Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
  [(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100

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.

• Dyslipidemias
• Coronary Heart Disease
• Combined (Atherogenic) Dyslipidemia
• Mixed Dyslipidemia

• Drug: ABT-335
  135 mg capsule, daily, 12 weeks
  Other Names:

  • ABT-335
  • TriLipix
  • Fenofibric acid
  • Choline Fenofibrate
• Drug: placebo
  placebo capsule, daily, 12 weeks
  Other Name: placebo
• Drug: atorvastatin
  40 mg, tablet, daily, 12 weeks
  Other Names:

  • atorvastatin
  • Lipitor
• Drug: ezetimibe
  10 mg capsule, daily, 12 weeks
  Other Names:

  • ezetimibe
  • Ezetrol
  • Zetia
  • Ezemibe

• Active Comparator: ABT-335 + atorvastatin + ezetimibe
  Interventions:

  • Drug: ABT-335
  • Drug: atorvastatin
  • Drug: ezetimibe
• Placebo Comparator: Placebo + atorvastatin + ezetimibe
  Interventions:

  • Drug: placebo
  • Drug: atorvastatin
  • Drug: ezetimibe

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.