NCT06949020已完成2 期
Efficacy and Safety of JMKX003142 Injection in Heart Failure Patients With Volume Overload：A Phase II, Randomized, Double-blind, Placebo-controlled Study
Jemincare1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年7月9日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- body weight
研究概览
简要总结
To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
- •Age ≥ 18 years old when signing the informed consent form;
- •At the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion;
- •The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:
- •1) At least 40mg/day of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics.
- •5. After the background treatment in the run-in period, the subject still has the following two conditions:
- •One of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion;
- •During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.
排除标准
- •Edema caused by diseases other than heart failure；
- •Subjects with ventricular assist devices during screening;
- •Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
- •Acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); History of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction);
- •Subjects with hypovolemia or suspected hypovolemia;
- •Subject cannot feel thirst or have difficulty in fluid intake during screening;
- •During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;
- •Administered with tolvaptan 14days before randomization ；
- •Pregnancy (female pregnancy test positive) or lactation period;
研究组 & 干预措施
placebo group
Placebo Comparator
干预措施: JMKX003142 placebo (Drug)
median dose group
Experimental
干预措施: JMKX003142 Injection (Drug)
low dose group
Experimental
干预措施: JMKX003142 Injection (Drug)
high dose group
Experimental
干预措施: JMKX003142 Injection (Drug)
结局指标
主要结局
body weight
时间窗: 5 days
次要结局
未报告次要终点
研究者
研究点 (1)
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