A Comparison of Telmisartan Effectiveness in Hypertensive Patients With and Without Albuminuria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,874
- 试验地点
- 936
- 主要终点
- Percentage of Patients With Controlled Blood Pressure
研究概览
简要总结
This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. The aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. Every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 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
结局指标
主要结局
Percentage of Patients With Controlled Blood Pressure
时间窗: approximately 12 weeks (10 to 14 weeks) after baseline
Systolic blood pressure (SBP) \< 140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg if the patient has: * no chronic renal insufficiency or macroalbuminuria-dipsticks negative, * albuminuria is \< 300 mg/24h or \< 200 mg albumin per gram of creatinine * no diabetes or SBP \< 130 mmHg and DBP \< 80 mmHg if the patient has: * chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine * diabetes (type 1 or 2)
次要结局
- Mean Difference in Systolic Blood Pressure(baseline and approximately 12 weeks)
- Mean Difference in Diastolic Blood Pressure(baseline and approximately 12 weeks)
- Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)(approximately 12 weeks (10 to 14 weeks) after baseline)
- Percentage of Patients Presenting an Adverse Event (AE)(baseline to the end of study period)
- Percentage of Patients With Positive to Negative Shift in Albuminuria(Approximately 12 weeks (10 to 14 weeks) after baseline)