NCT02070471已完成2 期
A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intravenous Single Injection LC28-0126 Immediately Before PCI (Percutaneous Coronary Intervention) in Patients With STEMI(ST-segment Elevation Myocardial Infarction)
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月最近更新:
适应症
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
- 60
- 试验地点
- 1
- 主要终点
- AUC of CK-MB for 72 hours post PCI
研究概览
简要总结
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI (ST-segment Elevation Myocardial Infarction)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 75
- •Within 12 hours after the onset of chest pain
- •ST-segment elevation of more than 0.1 mV in two contiguous leads or new LBBB(left bundle-branch block) patients
- •Signed for written informed consent
排除标准
- •Left Main disease
- •Multi-vessel disease
研究组 & 干预措施
LC28-0126 Dose A
Experimental
LC28-0126 Dose A
干预措施: LC28-0126 Dose A (Drug)
LC28-0126 Dose B
Experimental
LC28-0126 Dose B
干预措施: LC28-0126 Dose B (Drug)
LC28-0126 Dose C
Experimental
LC28-0126 Dose C
干预措施: LC28-0126 Dose C (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
AUC of CK-MB for 72 hours post PCI
时间窗: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
次要结局
- Infarct size and myocardial function assessed by CMR and Echocardiogram(Day 4, 30)
- AUC of Troponin I and CK for 72h post PCI(pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI PatientsST-segment Elevation Myocardial InfarctionNCT02770664LG Life Sciences100
已完成
1 期
A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.HealthyNCT03196804LG Chem32
已完成
2 期
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy SurgeryAcute PainNCT00877799Cara Therapeutics, Inc.114
已完成
1 期
Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male VolunteersHealthyNCT03653208ImmuneMed, Inc.56
已完成
3 期
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseNCT03782376Janssen-Cilag Ltd.215