Evaluation of the Real-life Efficacy and Safety of a Fixed-dose Telmisartan/Hydrochlorothiazide, Including Its Effect on Plasma Potassium and on Glucose and Lipid Metabolism Parameters in Patients With Essential Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,586
- 主要终点
- Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit
研究概览
简要总结
One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.
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
- •primary hypertension
- •age>18 years
排除标准
- •Cholestatic disorders or severe hepatic/renal failure
- •allergy to telmisartan or hydrochlorothiazide
- •treatment-resistant hypokalemia or hypercalcemia
- •pregnancy and lactation period
研究组 & 干预措施
Group 1
干预措施: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103) (Drug)
结局指标
主要结局
Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit
时间窗: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation
次要结局
- Change in plasma potassium between initial and final visit(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)
- Change in fasting plasma glucose between initial and final visit(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)
- Change in glycated haemoglobin A1C between initial and final visit(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)
- Change in plasma high density lipoprotein between initial and (continued)(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)
- Change in plasma low density lipoprotein between initial and final visit(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)
- Change in plasma cholesterol between initial and final visit(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)
- Change in plasma triglycerides between initial and final visit(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)
- Adverse events collection(approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation)