jRCT2080224182已完成2 期
An open-label, dose escalation, multicenter study to determine the effect on coronary blood flow and safety of NMB46 in subjects undergoing a clinically indicated cardiac catheterization.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-label, dose escalation, multicenter study
- 主要目的
- Diagnostic Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Included un the study will be subjects who:
- •Are undergoing a clinically indicated cardiac catheterization for evaluation and/ or treatment of suspected ischemic heart disease
- •Have a normal ECG or an abnormal ECG not considered to reflect ongoing or frequently recurrent ischemia at screening
排除标准
- •Exclusion from the study will be subjects who:
- •Have a history of coronary revascularization by either PCI or CABG within 6 months prior to dosing
- •Have a documented history of acute myocardial infarction or unstable angina within 1 month of dosing
- •Have uncontrolled hypertension
- •Have LVEF < 35%
- •Have aortic stenosis with valve area < 1.5 cm2
- •Have decompensated CHF and/ or New York Heart Association Class IV CHF
- •Have hypertrophic obstructive cardiomyopathy
- •Have asthma , chronic obstructive pulmonary disease or other reactive airway disease for which they are currently receiving treatment
- •Have a history of cardiac transplantation
- •Have a documented history or family history of long QT syndrome
- •Have a documented hypersensitivity to adenosine
- •Have a second- or third-degree AV block
- •Have a sinus node disease, such as sick sinus syndrome or symptomatic bradycardia
- •Have a severe hypotension
- •Known or suspected bronchoconstrictive or bronchospastic lung disease
- •Are unwilling to refrain from all long-acting vasodilating medications
- •Have demonstrable allergy to aminophylline, including allergy to its components (ethylenediamine and theophylline)
结局指标
主要结局
efficacy
The time (in seconds) that the ratio of APV to baseline APV following administration of NMB46 will be at least 2.0-fold.
次要结局
- Efficacy
- Safety
研究者
研究点 (1)
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