NL-OMON46553已完成不适用
Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment) - Bayer 18979
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Patients with stable CAD defined by
- •- clinically stable for at least 3 months
- •- coronary artery stenosis in any of the 3 main coronary vessels
- •- or history of myocardial infarction
- •* Sinus rhythm at screening
- •* Interpretable echocardiographic images
- •* Age: 30 to 80 years (inclusive)
- •* Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg/m²
排除标准
- •* Ejection fraction (EF) below 30% at screening
- •* Progressive angina with symptoms of worsening of angina within the <3 month
- •* History of recent myocardial infarction or unstable Angina
- •* Documented current relevant coronary stenosis *90% in any of the main 3 coronary vessels without bypass graft
- •* Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months prior to the first screening or patients with stroke at more than 3 months prior to the first Screening
- •* Insulin dependent diabetes mellitus
- •* Clinically significant and persisting cardiac ischemia
- •* Atrial fibrillation, pacemaker, defibrillator, second and third degree atrial-ventricular (AV) block
- •* Known clinically relevant ventricular arrhythmias
- •* Clinically relevant heart failure with reduced left ventricular ejection fraction
- •* Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis; any other moderate or severe valvular failures
- •* Valve replacement
- •* Hypertrophic obstructive cardiomyopathy (HOCM)
- •* Previous or imminent cardiac transplantation
- •* Known long QT syndrome or prolongation of the QT interval with ongoing proarrhythmic conditions
- •* Co-medication with drugs known to have QT prolonging effect
- •* Intolerance of fluoroquinolones, including moxifloxacin
- •* History of serious adverse effects e.g. tendinitis and tendon rupture, arthralgia and effects on the peripheral and central nervous system while taking fluoroquinolones including moxifloxacin
- •* History of tendon diseases or tendon injury caused by quinolones
- •* Treatment with fluoroquinolones, including moxifloxacin during the last 2 weeks
- •* Treatment with organic nitrates during the last 3 months prior to the first screening visit
- •* Treatment with riociguat during the last 3 months prior to the first screening visit
- •* Treatment with phosphodiesterase (PDE)-5 inhibitors during the last 14 days prior to the first screening visit
- •* Systolic blood pressure below 110 or above 160 mmHg at screening visit
- •* Diastolic blood pressure below 50 or above 100 mmHg at screening visit
- •* Heart rate below 50 or above 100 beats/min (taken from ECG measurement) at first screening visit
- •* Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at first screening visit
研究者
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