Levamlodipine Maleate (Xuanning) or Amlodipine Besylate (Norvasc) for Treatment of Hypertension: A Comparative Effectiveness Research
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- incidence of composite cardiovascular and cerebrovascular endpoints
研究概览
简要总结
The purpose of this study is to determine whether the effectiveness of levamlodipine maleate (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a Chinese primary hypertension population.
详细描述
It is a multicenter, prospective cohort study with large sample size. It is to evaluate the effect on the incidence of cardiovascular and cerebrovascular endpoint events and blood pressure control in hypertensive patients who use Levamlodipine Maleate (Xuanning) or amlodipine besylate(Norvasc).Xuanning group and Norvasc group will recruit 5000 patients respectively. Each site will recruit patients in chronological order；patients who participate will finish the two-year follow up(1,2,3,6,12,18,24 months after recruitment) and relevant data will be recorded. Baseline data will be analyzed to evaluate the equilibrium between two or more groups (such as the number of options). Logistic regression and propensity scores (PS) would be used to match major indicators of effectiveness and safety indicators using matching method baseline data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg or receiving antihypertensive drug treatment
- •Patient himself/herself or his/her family member has already signed the informed consent form
- •Patient is fit for use of Levamlodipine Maleate or amlodipine besylate
排除标准
- •patient with secondary hypertension
- •patients who has suffered from myocardial infarction or stroke within the latest 3 months
- •patients who has obvious intelligence、hearing and limb's activity disability
- •Patients with severe disease, with a life expectancy of less than two years
结局指标
主要结局
incidence of composite cardiovascular and cerebrovascular endpoints
时间窗: 2 years
quality of blood pressure control
时间窗: 2 years
次要结局
- incidence of adverse reaction(2 years)
- cost-effectiveness analysis(2 years)
- Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate(2 years)
研究者
Yong Huo
Professor of cardiovascular medicine
Peking University First Hospital