[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy and safety of SYH2062 injection in participants with mild to moderate essential hypertension.
主要目的
治疗后第12周动态血压24小时mSBP较基线的变化
次要目的 评价SYH2062注射液治疗后整个试验期间对动态血压均值的影响 评价SYH2062注射液治疗后整个试验期间对诊室血压的影响 评价SYH2062注射液在轻中度原发性高血压参与者中给药后的PK、PD特征 评价SYH2062注射液在轻中度原发性高血压参与者中给药后生物标志物表达水平的变化特征 评价SYH2062注射液在轻中度原发性高血压参与者中给药后免疫原性特征 评价SYH2062注射液在轻中度原发性高血压参与者中的安全性
[Translation] Primary Objective:
Changes in 24-hour ambulatory blood pressure (mSBP) from baseline at week 12 post-treatment.
Secondary Objectives:
Evaluate the effect of SYH2062 injection on mean ambulatory blood pressure throughout the trial period.
Evaluate the effect of SYH2062 injection on office blood pressure throughout the trial period.
Evaluate the pharmacokinetic (PK) and PD characteristics of SYH2062 injection in participants with mild to moderate essential hypertension.
Evaluate the changes in biomarker expression levels of SYH2062 injection in participants with mild to moderate essential hypertension.
Evaluate the immunogenicity of SYH2062 injection in participants with mild to moderate essential hypertension.
Evaluate the safety of SYH2062 injection in participants with mild to moderate essential hypertension.