Evaluation of the Effect of 0.4 mg Nitroglycerin Spray After Pretreatment With Multiple Once Daily Oral Doses of 2.5 mg, 5 mg and 10 mg Vericiguat (BAY 1021189) Each Given Over 14 ± 3 Days on Safety, Tolerability and Blood Pressure in a Multi-center, Randomized, Placebo-controlled, Double-blind Group Comparison Study in Stable Coronary Artery Disease (CAD) Patients Aged 30 to 80 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 36
- 主要终点
- Number of participants with adverse events as measure of safety and tolerability
研究概览
简要总结
This study is intended to investigate the effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable CAD defined by
- •coronary artery stenosis in any of the 3 main coronary vessels > 50% documented by coronary angiography within last 36 months or history of myocardial infarction
- •Age: 30 to 80 years
- •Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²
- •Female subjects must be of non-childbearing potential
排除标准
- •Intervention e.g. revascularization by percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) during the last 3 months
- •Progressive angina with symptoms of worsening of angina within the < 3 months
- •History of recent (< 6 months prior to the first screening examination) myocardial infarction or unstable angina
- •Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months prior or patients with stroke at more than 3 months prior with significant residual neurologic involvement
- •Insulin dependent diabetes mellitus
- •Clinically relevant cardiac ischemia
- •Clinical significant persistent ischemia
- •Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III
- •Systolic blood pressure below 110 or above 160 mmHg
- •Diastolic blood pressure above 100 mmHg
- •Heart rate below 50 or above 100 beats / min
- •Estimated glomerular filtration rate < 30 mL/min/1.73m2
研究组 & 干预措施
Vericiguat + Nitroglycerin
Co-administration of vericiguat and nitroglycerin
干预措施: Vericiguat (BAY1021189) (Drug)
Vericiguat + Nitroglycerin
Co-administration of vericiguat and nitroglycerin
干预措施: Nitroglycerin (Drug)
Placebo + Nitroglycerin
Aministration of matching placebo and nitroglycerin.
干预措施: Placebo (Drug)
Placebo + Nitroglycerin
Aministration of matching placebo and nitroglycerin.
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Number of participants with adverse events as measure of safety and tolerability
时间窗: approximately 1 year
次要结局
- Blood pressure(approximately 1 year)
- Heart rate(approximately 1 year)