The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.
Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment period with interim visits at weeks 4 and 8. 85 subjects were randomized into one of 3 treatment arms with equal probability. In treatment arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After 4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038 (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment. Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the entire 12 weeks of treatment. Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Pharmanet, Inc
Princeton, New Jersey, United States
Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments
Time frame: Baseline and 12 weeks of treatment
Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)
Time frame: Baseline and 12 weeks of treatment
Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.
Time frame: Baseline and 12 weeks of treatment
Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in HDL-C at 12 Weeks Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline
Time frame: baseline and 12 weeks of treatment
Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in Body Weight at 12 Weeks as Compared to Baseline
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Time frame: Baseline and 12 weeks of treatment