The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
543
135 mg capsule, daily, 12 weeks
placebo capsule, daily, 12 weeks
40 mg, tablet, daily, 12 weeks
10 mg capsule, daily, 12 weeks
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Columbiana, Alabama, United States
Unnamed facility
Hueytown, Alabama, United States
Unnamed facility
Ozark, Alabama, United States
Unnamed facility
Tuscaloosa, Alabama, United States
Unnamed facility
Median 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 Apolipoprotein AI (apoAI) From Baseline to Final Visit
\[(Week 12 apoAI minus baseline apoAI)/baseline apoAI\] 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 Apolipoprotein CIII (apoCIII) From Baseline to Final Visit
\[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII\] 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 Apolipoprotein B (apoB) From Baseline to Final Visit
\[(Week 12 apoB minus baseline apoB)/baseline apoB\] x 100
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sierra Vista, Arizona, United States
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Carmichael, California, United States
Unnamed facility
Concord, California, United States
Unnamed facility
Long Beach, California, United States
...and 108 more locations