NCT07021976进行中（未招募）3 期
A Multicentre, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in the Treatment of Obstructive Hypertrophic Cardiomyopathy
Shandong Suncadia Medicine Co., Ltd.3 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2025年8月11日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 228
- 试验地点
- 3
- 主要终点
- The clinical response rate of treatment with HRS-1893.
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old, gender unlimited.
- •BMI<35 kg/m
- •The diagnosis was obstructive hypertrophic cardiomyopathy.
- •Laboratory determination of echocardiography showed that Rest LVOT-G≥50 mmHg, or Rest LVOT-G≥30 mmHg and LVOT-G≥50 mmHg after Valsalva action.
- •Echocardiographic laboratory tests showed LVEF≥60%.
- •NYHA classification: Grade II - III.
- •Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
排除标准
- •Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
- •Had a history of severe valvular heart disease.
- •Abnormal laboratory test results during screening, or any other clinically significant abnormal screening laboratory values, which are determined by the researcher to be unsuitable for inclusion.
- •Other circumstances where the researchers consider the subjects unsuitable to participate in this trial, such as physical or mental illnesses or conditions that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.
研究组 & 干预措施
HRS-1893 Group
Experimental
干预措施: HRS-1893 Tablets (Drug)
HRS-1893 Placebo Group
Placebo Comparator
干预措施: HRS-1893 Placebo Tablets (Drug)
结局指标
主要结局
The clinical response rate of treatment with HRS-1893.
时间窗: After 24 weeks of HRS-1893 treatment.
次要结局
- The incidence of major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular events).(About 29 weeks.)
- Incidence and severity of any adverse events.(About 29 weeks.)
- The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline.(Week 12 and Week 24.)
研究者
研究点 (3)
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