[Translation] A multicenter, randomized, double-blind, positive-controlled, parallel-group Phase II clinical study on the efficacy and safety of OR12000 compound tablets in the treatment of patients with moderate to severe essential hypertension
1. 比较QR12000复方片与其单方QR01019钾盐在中、重度原发性高血压患者中的降压效果。
2. 比较QR12000复方片与缬沙坦在中、重度原发性高血压患者中的降压效果。
3. 比较QR12000复方片与诺欣妥在中、重度原发性高血压患者中的降压效果。
4. 评估QR12000复方片在中、重度原发性高血压患者的安全性。
5. 评估QR12000复方片在中、重度原发性高血压患者中生物标志物的特征。
6. 评估QR12000复方片中主要活性成分在中重度原发性高血压患者中的药代动力学(PK)特征及PK-PD关系。
[Translation] 1. To compare the antihypertensive effects of QR12000 compound tablets and its single QR01019 potassium salt in patients with moderate and severe essential hypertension.
2. To compare the antihypertensive effects of QR12000 compound tablets and valsartan in patients with moderate and severe essential hypertension.
3. To compare the antihypertensive effects of QR12000 compound tablets and Entresto in patients with moderate and severe essential hypertension.
4. To evaluate the safety of QR12000 compound tablets in patients with moderate and severe essential hypertension.
5. To evaluate the characteristics of biomarkers of QR12000 compound tablets in patients with moderate and severe essential hypertension.
6. To evaluate the pharmacokinetic (PK) characteristics and PK-PD relationship of the main active ingredients in QR12000 compound tablets in patients with moderate and severe essential hypertension.