2023-510148-19-00招募中2 期
A Phase IIb Two-cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart Failure
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 235
- 试验地点
- 29
- 主要终点
- Change in echocardiographic measurements from Baseline to Week 25
研究概览
简要总结
To evaluate the effect and dose response of AZD5462 after 24 weeks of treatment in participants with HF.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up period
- 盲法
- Double (Analyst, Investigator, Carer, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 years (or the legal age of consent in the jurisdiction in which the study is taking place) to 85 years of age, inclusive, at the time of signing the ICF.
- •Participants must have a pre-existing diagnosis of HF NYHA FC II to IV
- •Participants must be on stable HF standard of care medications for at least 4 weeks prior to consent and during the Screening period. If the participant is currently taking diuretics, then diuretics must also be stable for at least 1 week prior to consent (minor dose adjustments in diuretics are allowed based on the investigator’s judgment).
- •Minimum BMI of 18 kg/m2 at Screening.
- •Participants LVEF must be centrally confirmed at Screening
- •Participants NT-pro-BNP must be centrally confirmed at screening
- •For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential.
- •Capable of giving and willing to give signed informed consent
排除标准
- •Historical or current evidence of a clinically significant disease or disorder.
- •History of hypersensitivity to AZD5462 or any component of AZD5462 drug product.
- •Poor acoustic window on 2-chamber and 4-chamber views, as determined by the sonographer.
- •Any planned highly invasive cardiovascular procedure
- •Participants requiring iron infusion during the study.
- •Any laboratory values outside of the defined range at Screening
- •Vital signs outside of the defined range at Screening
结局指标
主要结局
Change in echocardiographic measurements from Baseline to Week 25
Change in echocardiographic measurements from Baseline to Week 25
次要结局
- Change in echocardiographic measurements from Baseline to Week 13 and Week 25
- • Change in Health Status from Baseline to Week 3, Week 5, Week 13, and Week 25 • Change in NYHA FC from Baseline to Week 25
- Change echocardiographic measurements from baseline to week 25
- Change in cardiac biomarkers from Baseline to Week 5, Week 13, and Week 25
- AZD5462 plasma PK concentrations
研究者
AstraZeneca Clinical Study Information Centre
Scientific
AstraZeneca AB
研究点 (29)
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