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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
657
135 mg, daily, 12 weeks
daily, 12 weeks, see Arm Description for dosage information
Daily, 12 weeks, see Arm Description for placebo information
Global Medical Information
North Chicago, Illinois, United States
Mean Percent Change in Triglycerides From Baseline to Final Visit
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: Baseline to 12 Weeks (Final Visit)