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 Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia

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

Intervention / Treatment
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* Drug: ABT-335
* Drug: placebo
* Drug: atorvastatin
* Drug: ezetimibe


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABT-335 + atorvastatin + ezetimibe<br> | Drug: ABT-335<br>* 135 mg capsule, daily, 12 weeks<br>* Other names: Choline Fenofibrate;Drug: atorvastatin<br>* 40 mg, tablet, daily, 12 weeks<br>* Other names: Lipitor;Drug: ezetimibe<br>* 10 mg capsule, daily, 12 weeks<br>* Other names: Ezemibe;|
| Placebo Comparator: Placebo + atorvastatin + ezetimibe<br> | Drug: placebo<br>* placebo capsule, daily, 12 weeks<br>Drug: atorvastatin<br>* 40 mg, tablet, daily, 12 weeks<br>* Other names: Lipitor;Drug: ezetimibe<br>* 10 mg capsule, daily, 12 weeks<br>* Other names: Ezemibe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percent Change in Triglycerides From Baseline to Final Visit | [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100 | Baseline to 12 Weeks (Final Visit) | 
| Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit | [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100 | Baseline to 12 weeks (Final Visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit | [(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100 | Baseline to 12 weeks (Final Visit) | 
| Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit | [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100 | Baseline to 12 weeks (final visit) | 
| Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit | [(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100 | Baseline to 12 weeks (Final Visit) | 
| Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit | [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100 | Baseline to 12 weeks (Final Visit) | 
| Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit | [(Week 12 apoB minus baseline apoB)/baseline apoB] x 100 | Baseline to 12 weeks (Final Visit) | 
| Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit | [(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100 | Baseline to 12 weeks (Final Visit) |