Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

Study Overview
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Brief Summary
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The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Official Title
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A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia

Conditions
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Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia

Intervention / Treatment
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* Drug: ABT-335 and rosuvastatin calcium
* Drug: ABT-335 and atorvastatin calcium
* Drug: ABT-335 and simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female subjects who voluntarily sign the informed consent. Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies. Exclusion Criteria: Subject is using or will use investigational medications, except as approved by Abbott. Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>20 mg drug and ABT-335 | Drug: ABT-335 and rosuvastatin calcium<br>* ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks<br>* Other names: TRILIPIX;|
| Active Comparator: B<br>40 mg drug and ABT 335 | Drug: ABT-335 and atorvastatin calcium<br>* ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks<br>* Other names: TRILIPIX;|
| Active Comparator: C<br>40 mg drug and ABT-335 | Drug: ABT-335 and simvastatin<br>* ABT-335 135 mg plus simvastatin daily, 52 weeks<br>* Other names: TRILIPIX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study |  | Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study |  | Baseline to Week 52 of the open-label study | 
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study |  | Baseline to Week 52 of the open-label study | 
| Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study |  | Baseline to Week 52 of the open-label study | 
| Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study |  | Baseline to Week 52 in this open-label study | 
| Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study |  | Baseline to Week 52 of the open-label study | 
| Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study |  | Baseline to Week 52 of the open-label study | 
| Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study |  | Baseline to Week 52 of the open-label study | 
| Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study |  | Baseline to Week 52 of the open-label study |