A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

Detailed Description
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There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).

Official Title
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A 12-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia

Conditions
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Hypercholesterolemia, Dyslipidemia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Adult male and female participants who voluntarily sign the informed consent. Fasting lipid results following greater than 12-hour fasting period: Triglycerides level greater than or equal to 150 mg/dL, High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL. Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet. Exclusion Criteria Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study. Participants receiving coumarin anticoagulants or systemic cyclosporine.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-335 and Rosuvastatin Calcium<br>ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks | Drug: ABT-335 and rosuvastatin calcium<br>* ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks<br>* Other names: ABT-335 / Rosuvastatin Combination (ABT-143);|
| Active Comparator: ABT-335<br>ABT-335 135mg monotherapy administered orally, once daily for 12 weeks | Drug: ABT-335<br>* ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks<br>* Other names: fenofibric acid;|
| Active Comparator: Rosuvastatin Calcium<br>Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks | Drug: rosuvastatin calcium<br>* Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks<br>* Other names: Rosuvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) | The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | 
| Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) | The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | 
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. | Baseline to 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) | The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. | Baseline to 12 Weeks | 
| Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) | The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | 
| Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) | The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | 
| Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set) | The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | 
| Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) | The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | 
| Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) | The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks |