CTRI/2024/12/078408招募中2 期
A Phase IIb Two-Cohort, Randomised, Placebo-controlled, Doubleblind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 4
- 主要终点
- To evaluate the effect of AZD5462 after treatment in participants with HF
研究概览
简要总结
The purpose of this study is to measure efficacy and safety of AZD5462 compared to placebo in adult participants with HF
The study will include 3 periods and approximately 12 study visits:
Screening period of up to 4 weeks, with at least one study visit
Treatment period of 24 weeks, with 8 study visits
Follow-up period of 4 weeks, with 3 study visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
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 III Participants must be on stable HF standard of care medication for at least 4 weeks prior to consent and during the Screening period Minimum body mass index (BMI) of 18 kilograms per meter square (kg/m2) at Screening For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential All male participants should refrain from fathering a child or donating sperm until 3 months after the final study Follow-up Visit.
- •Non-sterilised male participants should avoid fathering a child either by true abstinence or use of a condom for all sexual intercourse with a female partner of childbearing potential from the first dose until 3 months after the final Follow-up Visit.
排除标准
- •Historical or current evidence of a clinically significant disease or disorder including, but not limited to:
- •Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, or percutaneous coronary intervention within 12 weeks prior to Screening or transcatheter structural heart interventions or cardiac valve surgery within 6 months prior to Screening
- •Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic (obstructive) cardiomyopathy
- •History of untreated clinically significant valve disease or a Screening confirmation of severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency or severe mitral insufficiency
- •Amyloidosis, Fabry disease, or haemochromatosis.
- •Pericardial disease (i.e., visually significant white pericardium on echocardiogram)
- •Known coagulation disorders
- •Current diagnosis of active hepatitis
- •Severe pulmonary disease that is not expected to improve over time, as assessed by the investigator
- •Decompensated HF or any cardiopulmonary hospitalisation within 4 weeks prior to Screening History of active malignancy within 2 years, except for fully excised or treated basal cell carcinoma, or less than or equal to 2 squamous cell carcinomas of the skin and participants who are under investigation for breast or cervical cancer, including participants with a pap smear of grade greater than or equal to 3 History of hypersensitivity to drugs with a similar chemical structure or class to AZD5462 or any component of AZD5462 drug product Known history of drug or alcohol abuse within 24 months of Screening Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication Cardiac ventricular arrhythmia that requires treatment History of or anticipated heart transplant.
- •Current or planned cardiac resynchronization therapy or bi ventricular pacemaker or mechanical assist device implantation.
- •Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter etc).
- •Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at Screening Known to have historically tested positive for Human immunodeficiency virus.
结局指标
主要结局
To evaluate the effect of AZD5462 after treatment in participants with HF
时间窗: From Baseline to Week 25
次要结局
- To evaluate the effect and dose response of AZD5462 and effect on echocardiographic markers related to structural, systolic and diastolic function after treatment in participants with HF(From Baseline to Week 13 and Week 25)
- To evaluate the effect of AZD5462 on HF health status in participants with HF.
- To evaluate the effect of AZD5462 on biomarkers of cardiac function in treatment participants with HF(From Baseline to Weeks 5, 13, and 25)
- To evaluate the PK of AZD5462 after repeat OD oral dosing in participants with HF(Day 15 (Week 3), Day 29 (Week 5) and Day 85 (Week 13))
- To evaluate the safety and tolerability of AZD5462 as compared to placebo in participants with HF(From Baseline to Week 29 (Day 197))
研究者
研究点 (4)
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