Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid 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 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia

Conditions
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Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia

Intervention / Treatment
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* Drug: ABT-335
* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with mixed dyslipidemia Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet. Exclusion Criteria: Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial. Patients who are taking certain medications or unstable dose of specific 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>ABT-335 + 20 mg simvastatin | Drug: ABT-335<br>* 135 mg, daily, 12 weeks<br>Drug: Simvastatin<br>* daily, 12 weeks, see Arm Description for dosage information<br>|
| Active Comparator: B<br>ABT-335 + 40 mg simvastatin | Drug: ABT-335<br>* 135 mg, daily, 12 weeks<br>Drug: Simvastatin<br>* daily, 12 weeks, see Arm Description for dosage information<br>|
| Placebo Comparator: C<br>ABT-335 monotherapy | Drug: ABT-335<br>* 135 mg, daily, 12 weeks<br>Drug: Placebo<br>* Daily, 12 weeks, see Arm Description for placebo information<br>|
| Placebo Comparator: D<br>20 mg simvastatin monotherapy | Drug: Simvastatin<br>* daily, 12 weeks, see Arm Description for dosage information<br>Drug: Placebo<br>* Daily, 12 weeks, see Arm Description for placebo information<br>|
| Placebo Comparator: E<br>40 mg simvastatin monotherapy | Drug: Simvastatin<br>* daily, 12 weeks, see Arm Description for dosage information<br>Drug: Placebo<br>* Daily, 12 weeks, see Arm Description for placebo information<br>|
| Placebo Comparator: F<br>80 mg simvastatin monotherapy | Drug: Simvastatin<br>* daily, 12 weeks, see Arm Description for dosage information<br>Drug: Placebo<br>* Daily, 12 weeks, see Arm Description for placebo information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 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) | 
| Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit | [(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100 | Baseline to 12 Weeks (Final Visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 Total Cholesterol From Baseline to Final Visit | [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100 | Baseline to 12 Weeks (Final Visit) | 
| Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit | [(Week 12 Apo B minus baseline Apo B)/baseline Apo B] 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia