NCT06816251已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年2月25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
- 84
- 试验地点
- 2
- 主要终点
- The incidence of left ventricular ejection fraction (LVEF) < 50%
研究概览
简要总结
This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-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 (including boundary value), male or female.
- •Body mass index < 35 kg/m
- •Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
- •Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
- •Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.
排除标准
- •Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
- •Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
- •History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- •Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
- •Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
研究组 & 干预措施
HRS-1893 low-dose group
Experimental
干预措施: HRS-1893 (Drug)
HRS-1893 high-dose group
Experimental
干预措施: HRS-1893 (Drug)
HRS-1893 placebo high-dose group
Placebo Comparator
干预措施: HRS-1893 placebo (Drug)
HRS-1893 placebo low-dose group
Placebo Comparator
干预措施: HRS-1893 placebo (Drug)
结局指标
主要结局
The incidence of left ventricular ejection fraction (LVEF) < 50%
时间窗: Up to 14 weeks.
Adverse events (AEs)
时间窗: Up to 14 weeks.
次要结局
- Peak oxygen uptake (pVO2) value(About 12 weeks.)
- The cardiac troponin value(About 12 weeks.)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
A study to test the efficacy and safety of padsevonil as treatment of focal-onset seizures in adult subjects with drug-resistant epilepsyFocal-Onset SeizuresMedDRA version: 21.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852EUCTR2018-002303-33-BECB Biopharma SR625
招募中
3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate CancerNon-Metastatic Castration-Resistant Prostate Cancernon-spread Castration-Resistant Prostate Cancer10036958NL-OMON54510Aragon Pharmaceuticals, Inc.35
进行中（未招募）
1 期
A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseEUCTR2019-002531-29-GBVisterra, Inc.144
进行中（未招募）
不适用
Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary SyndromeType 2 diabetes mellitus (T2DM) and acute coronary syndrome (ACS)MedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2009-011222-34-SETakeda Development Centre Europe Ltd.5,400
进行中（未招募）
不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin, Alone.Type 2 Diabetes MellitusEUCTR2009-010224-25-HUBristol-Myers Squibb International Corporation152