[Translation] A randomized, double-blind, parallel controlled phase III clinical trial to evaluate the efficacy and safety of the triple combination of olmesartan medoxomil/amlodipine/hydrochlorothiazide tablets in the treatment of essential hypertension using the double combination of olmesartan medoxomil/hydrochlorothiazide tablets as a control
以二复方奥美沙坦酯/氢氯噻嗪片为对照,评价三复方奥美沙坦酯/氨氯地平/氢氯噻嗪片治疗原发性高血压患者的疗效和安全性。主要终点为随机分组至双盲治疗期8周结束,平均坐位舒张压(msDBP)的变化。次要终点为从随机分组至双盲治疗期8周结束,平均坐位收缩压(msSBP)的变化;从随机分组至双盲治疗期4 周结束,msDBP 和msSBP 的变化;双盲治疗期第4和8周结束,达到目标血压的受试者[msSBP/msDBP<140/90 mmHg 或糖尿病、慢性肾脏病患者(肌酐清除率≥30 mL/min 和≤60 mL/min)msSBP/msDBP< 130/80 mmHg]百分比。
[Translation] The efficacy and safety of the combination of olmesartan medoxomil/amlodipine/hydrochlorothiazide tablets in the treatment of patients with essential hypertension were evaluated using the combination of olmesartan medoxomil/hydrochlorothiazide tablets as a control. The primary endpoint was the change in mean sitting diastolic blood pressure (msDBP) from randomization to the end of the 8-week double-blind treatment period. The secondary endpoints were the change in mean sitting systolic blood pressure (msSBP) from randomization to the end of the 8-week double-blind treatment period; the change in msDBP and msSBP from randomization to the end of the 4-week double-blind treatment period; and the percentage of subjects who reached the target blood pressure [msSBP/msDBP < 140/90 mmHg or msSBP/msDBP < 130/80 mmHg in patients with diabetes or chronic kidney disease (creatinine clearance ≥ 30 mL/min and ≤ 60 mL/min)] at the end of the 4th and 8th weeks of the double-blind treatment period.