A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin Combination Tablets and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Percentage change in LDL-C levels from baseline after 6 weeks of study treatment
研究概览
简要总结
To evaluate the efficacy and the safety of concomitant use of Ezetimibe/Rosuvastatin combination tablets and Candesartan cilexetil/Amlodipine besylate combination tablets compared to each combination tablet alone in patients with essential hypertension (HTN) and hyperlipidemia.
详细描述
To improve the ease of use of high blood pressure and hyperlipidemia to improve patient compliance and reduce the risk of cardiovascular disease.
And It is recommended to identify the need to develop a combination of Candesartan cilexetil/Amlodipine besylate combination tablets , and Ezetimibe/Rosuvastatin combination tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EZE/ROS+CAN/AML
Ezetimibe/Rosuvastatin 10 mg/10 mg and Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks
干预措施: Ezetimibe/Rosuvastatin (Drug)
CAN/AML
Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks
干预措施: Candesartan cilexetil/Amlodipine besylate (Drug)
EZE/ROS+CAN
Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg, once a day for 6 weeks
干预措施: Candesartan cilexetil (Drug)
结局指标
主要结局
Percentage change in LDL-C levels from baseline after 6 weeks of study treatment
时间窗: week 6
EZE/ROS + CAN/AML arm vs. CAN/AML arm Percentage change in LDL-C levels from baseline after 6 weeks of study treatment For the percentage change in LDL-C levels at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage change in baseline-adjusted LDL-C levels from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.
Change in sitting Systolic Blood Pressure(siSBP) from baseline after 6 weeks of study treatment
时间窗: week 6
EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm Change in siSBP from baseline after 6 weeks of study treatment For the siSBP at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the analysis of covariance (ANCOVA) with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.
次要结局
- Percentage changes in LDL-C levels from baseline after 3 and 6 weeks of study treatment(week 3 and week 6)
- Proportions of subjects who achieve the treatment goal based on NCEP ATP III Guideline from baseline after 3 and 6 weeks of study treatment(week 3 and week 6)
- Percentage change in LDL-C levels from baseline after 3 weeks of study treatment(week 3)
- Percentage changes in TC, TG, HDL-C, apolipoprotein B, and CRP levels from baseline after 3 and 6 weeks of study treatment(week 3 and week 6)
- Change in siSBP from baseline after 3 weeks of study treatment(week 3)
- Changes in siSBPs from baseline after 3 and 6 weeks of study treatment(week 3 and week 6)
- Percentage changes in LDL-C/HDL-C and TC/HDL-C from baseline after 3 and 6 weeks of study treatment(week 3 and week 6)
- Changes in siDBPs from baseline after 3 and 6 weeks of study treatment(week 3 and week 6)
- Proportions of subjects who achieve the treatment goal based on JNC VIII Guideline from baseline after 3 and 6 weeks of study treatment(week 3 and week 6)