Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 49
- 主要终点
- Change in Systolic Blood Pressure From Baseline to Study End
研究概览
简要总结
The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with arterial hypertension
干预措施: Telmisartan or Telmisartan and Hydrochlorthiazide (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure From Baseline to Study End
时间窗: From baseline to visit 3 (6 months)
Change in Diastolic Blood Pressure From Baseline to Study End
时间窗: From baseline to visit 3 (6 months)
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End
时间窗: From baseline to visit 3 (6 months)
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End
时间窗: From baseline to visit 3 (6 months)
10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End
时间窗: From baseline to visit 3 (6 months)
ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
次要结局
- Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)(Visit 3 (6 months from baseline))
- Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)(6 Months)
- Change in Heart Rate From Baseline to Study End(From baseline to visit 3 (6 months))
- Number of Participants Not Completing Study(3rd visit (6 months))
- Number of Patients With Adverse Events (AE)(6 months)