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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,911
ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
ABT-335 135 mg plus simvastatin daily, 52 weeks
Global Medical Information
North Chicago, Illinois, United States
Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
Time frame: 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
Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 52 of the open-label study
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Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study
Time frame: Baseline to Week 52 of the open-label study