EUCTR2012-005129-57-CZ进行中（未招募）不适用
The Efficacy and Safety of Valsartan and Combination of Valsartan and Hydrochlorothiazide in the Treatment of Patients with mild to moderate Arterial Hypertension.
KRKA CR, s.r.o.0 个研究点目标入组 500 人开始时间: 2013年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients of both genders with mild to moderate essential hypertension (according to European Guidelines for the management of arterial hypertension 2007) with:
- •I.systolic blood pressure of 140 – 179 mm Hg and
- •II.diastolic blood pressure of 90 – 109 mm Hg;
- •Age 18 years or above;
- •Written informed consent provided by patients or legally acceptable representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Blood pressure values 180/110 mm Hg or higher during washout period (hypertensive crisis);
- •Secondary hypertension (due to renovascular hypertension, diseases of endocrine system (pheochromocytoma, primary hyperaldosteronism, Cushing’s syndrome, acromegaly)), malignant hypertension, treatment-resistent hypertension;
- •Hipovolemia due to salt-restricted diet, dyalisis, diarrhea or vomiting;
- •Hemodynamically significant aortic stenosis or bilateral stenosis of the renal artery or arterial stenosis of a solitary kidney;
- •History of angioedema (hereditary, idiopathic or related to previous treatment);
- •Hypertensive encephalopathy;
- •Angina pectoris or heart failure requiring treatment with a ß-blocker or a calcium antagonist or cardiovascular accident (unstable angina pectoris, myocardial infarction, transitory ischemic attack-stroke or cerebrovascular insult) within former three months;
- •Acute liver disease or hepatic dysfunction and other acute diseases (infection, acute exacerbation of chronic diseases, trauma, surgical intervention) within the period of the past three months;
- •Renal failure (creatinin clearance < 60 mL/min) or clinically significant pathologic laboratory values of serum creatinine or potassium;
- •Diabetes mellitus treated with insulin or uncontrolled diabetes mellitus with fasting blood glucose greater than 11 mmol/L;
- •Concomitant treatment that might influence the final therapeutic effect of the tested active substances (see chapter 6.3);
- •Pathological clinical states that could affect patient’s compliance, or have any impact on patient’s survival rate (malignant diseases, alcohol abuse, medicine addiction, psychiatric diseases);
- •Pregnancy or breast-feeding (in women of childbearing potential a urine pregnancy test will be performed);
- •Hypersensitivity to any of the tested medicines;
- •Participation in another clinical trial within thirty days prior to enrolment;
- •Patients who are not able out of any reason to fulfil the requirements of the Protocol.
研究者
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