[Translation] A randomized, double-blind, placebo-controlled, multicenter, dose-ranging, Phase IIb study evaluating AZD3427 in subjects with heart failure and left heart disease-induced pulmonary hypertension (WHO Category 2)
主要目的:评估AZD3427治疗24周后对HF合并PH(第2大类)受试者PVR的影响。
次要目的:评估AZD3427治疗24周后对HF合并PH(第2大类)受试者心脏功能的其他血流动力学标志物的影响;评估AZD3427治疗24周后对HF合并PH(第2大类)受试者功能和症状的影响;评估AZD3427治疗12周和24周后对HF合并PH(第2大类)受试者心脏和肾功能生物标志物的影响;评估HF合并PH(第2大类)受试者重复Q2W SC给药后AZD3427的PK;评价AZD3427的免疫原性。
安全性目的:评估AZD3427与安慰剂相比在HF合并PH(第2大类)受试者中的安全性和耐受性。
[Translation] Primary objective: To evaluate the effect of AZD3427 on PVR in subjects with HF and PH (category 2) after 24 weeks of treatment.
Secondary objectives: To evaluate the effect of AZD3427 on other hemodynamic markers of cardiac function in subjects with HF and PH (category 2) after 24 weeks of treatment; To evaluate the effect of AZD3427 on function and symptoms in subjects with HF and PH (category 2) after 24 weeks of treatment; To evaluate the effect of AZD3427 on cardiac and renal function biomarkers in subjects with HF and PH (category 2) after 12 and 24 weeks of treatment; To evaluate the PK of AZD3427 after repeated Q2W SC administration in subjects with HF and PH (category 2); To evaluate the immunogenicity of AZD3427.
Safety objective: To evaluate the safety and tolerability of AZD3427 compared with placebo in subjects with HF and PH (category 2).