NCT01351636已完成4 期
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial
Sumitomo Pharma (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Composite endpoints
研究概览
简要总结
The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-75 years-old;
- •Chronic kidney disease stage 5 with haemodialysis treatment for 2 months;
- •Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks;
- •Patients who receiving alfa or beta blockers will be washed out for 2 weeks;
- •Written informed consent
排除标准
- •Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months;
- •Patients who taking class I antiarrhythmic drugs;
- •Resting heart rate less than 60;
- •Patients with systolic pressure less than 90 mmHg;
- •Patients with chronic obstructive pulmonary disease and asthma;
- •Patients with cerebral infarction in the last 2 weeks;
- •Severe disorders of liver function;
- •Allergy to the arotinolol;
- •Patients who planning to have kidney transplantation in the near future;
- •Pregnancy and breast-feeding;
- •Malignant tumor
研究组 & 干预措施
Arotinolol Hydrochloride
Experimental
Antihypertensive medications plus arotinolol hydrochloride
干预措施: Arotinolol Hydrochloride (Drug)
Non arotinolol group
Placebo Comparator
Antihypertensive medications without arotinolol hydrochloride
干预措施: Non arotinolol group (Drug)
结局指标
主要结局
Composite endpoints
时间窗: 18 months
次要结局
- Changes for metabolism related index(18 months)
- Blood pressure control in hypertensive haemodialysis patients(18 months)
研究者
研究点 (1)
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