[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study evaluating the efficacy and safety of YKYY029 injection in patients with mild to moderate hypertension.
主要目的
评价YKYY029注射液在轻中度高血压患者中,治疗第3个月时对收缩压(SBP)的影响;
次要目的
评价YKYY029注射液在轻中度高血压患者中,治疗第3个月时对舒张压(DBP)的影响。
评价YKYY029注射液在轻中度高血压患者中,治疗后第6个月、9个月、12个月对SBP和DBP的影响。
评价YKYY029注射液在轻中度高血压患者中,治疗后第3个月、6个月、9个月、12个月SBP、DBP的动态变化。
评价YKYY029注射液对血压昼夜节律的影响。
评价YKYY029注射液在轻中度高血压患者中多次给药治疗的安全性。
评价YKYY029注射液在参与者中的药代动力学(PK)特征。
评价YKYY029注射液在参与者中的药效动力学(PD)特征。
评价YKYY029注射液在参与者中的免疫原性。
[Translation] Primary Objective: To evaluate the effect of YKYY029 injection on systolic blood pressure (SBP) at month 3 in patients with mild to moderate hypertension.
Secondary Objectives: To evaluate the effect of YKYY029 injection on diastolic blood pressure (DBP) at month 3 in patients with mild to moderate hypertension.
To evaluate the effect of YKYY029 injection on SBP and DBP at months 6, 9, and 12 in patients with mild to moderate hypertension.
To evaluate the dynamic changes in SBP and DBP at months 3, 6, 9, and 12 in patients with mild to moderate hypertension.
To evaluate the effect of YKYY029 injection on the diurnal rhythm of blood pressure.
To evaluate the safety of repeated-dose treatment with YKYY029 injection in patients with mild to moderate hypertension.
To evaluate the pharmacokinetic (PK) characteristics of YKYY029 injection in participants.
To evaluate the pharmacodynamic (PD) characteristics of YKYY029 injection in participants.
To evaluate the immunogenicity of YKYY029 injection in participants.