Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-Blind, Active Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination BMS-201038 (AEGR-733) and Ezetimibe vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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