[Translation] A randomized, double-sided trial to evaluate the efficacy and safety of ezetimibe/rosuvastatin single-tablet combination (SPC) in Chinese adults with primary hypercholesterolemia with poor lipid control on statin therapy. Blind, double-dummy, active control, parallel design, phase III clinical trial
主要目的:
证明与瑞舒伐他汀10 mg(R10)相比,依折麦布10 mg/瑞舒伐他汀10 mg(E10/R10)单片复方制剂治疗8周后降低低密度脂蛋白胆固醇(low-density lipoprotein cholesterol,LDL-C)具有优效性
次要目的:
评价达到LDL-C目标值的患者比例
评价治疗4周后SPC(E10/R10)相较于R10降低LDL-C的疗效
评价治疗4周和8周后SPC(E10/R10)相较于R10降低其他血脂指标的疗效
评价SPC(E10/R10)和R10的安全性
[Translation] main purpose:
Prove that compared with rosuvastatin 10 mg (R10), ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) single-tablet combination treatment reduces low-density lipoprotein cholesterol (low-density lipoprotein cholesterol) after 8 weeks of treatment lipoprotein cholesterol, LDL-C) has superiority
Secondary purpose:
Assess the proportion of patients achieving LDL-C target values
To evaluate the efficacy of SPC (E10/R10) in reducing LDL-C compared with R10 after 4 weeks of treatment
To evaluate the efficacy of SPC (E10/R10) in reducing other blood lipid indexes compared with R10 after 4 and 8 weeks of treatment
Evaluating the safety of SPC (E10/R10) and R10