EUCTR2006-001998-25-DE进行中（未招募）不适用
Double-blind, randomised trial to investigate the antihypertensive and metabolic effects of candesartan in insulin-resistant obese patients with a hypertension not adequately controlled by previous beta-blocker or calcium channel blocker
Takeda Pharma GmbH0 个研究点开始时间: 2006年7月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Outpatients aged from 35 to 70 years inclusive (men) and 45 to 70 years inclusive (women); Abdominal obesity with a waist circumference > 102 cm (men) and > 88 cm (women); Body mass index (BMI) > 30 kg/m2; Hypertension not adequately controlled (seated diastolic blood pressure (DBP) > 95 mmHg and <= 110 mmHg) by monotherapy with either beta-blocker or calcium channel blocker; Homeostasis Model Assessment (HOMA)-Insulin Resistance index > 2.5;
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Existing HCT therapy at start of study; diabetes mellitus type 1 or 2[known or newly detected (Screening:FPG>7.0mmol/L); Chronic renal impairment or S-creatinine >= 1.8 mg/dL;Presence of single kidney or state after kidney transplantation or known bilateral renal artery stenosis (RAS) or interventional treatment for RAS in the last year;Hyperkalaemia (potassium >5.5mmol/l); Nephrotic syndrome; Thyroid dysfunction; Primary or secondary hyperaldosteronismus; Cushing syndrome; Known or suspected familial hypercholesterolaemia; Severe hepatic impairment; History of chronic heart failure; History of overt coronary heart disease; History of silent myocardial infarction;Hemodynamically relevant stenosis of the mitral and/or aortic valve; History of stroke; Stage 3 hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); ACE inhibitor or ARB therapy in the previous 4 weeks; Lipid-lowering therapy with CSE inhibitors or anticipated initiation of such a therapy; History of autoimmune disease; History of cancer in the last 5 years or wasting disease; Pregnancy or breast feeding woman or woman wishing to become pregnant in the planned period of the study; Woman of childbearing potential not using highly effective methods of birth control (Note: A highly effective method of birth control is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly; Breast feeding; Patients who are in a dependent relationship with the investigator or sponsor or may consent under stress.
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