EUCTR2008-005006-39-IT进行中（未招募）不适用
Study on the vascular effects of ACE-I + CA-antagonist (Enalapril + Lercanidipine) versus ACE-I + diuretic (Enalapril + hydrochlorothiazidE) combinations in hypertensive patients with metabolic syndrome not sufficiently controlled by ACE-I monotherapy - ND
AZIENDA OSPEDALIERA PISANA0 个研究点开始时间: 2009年2月19日最近更新:
适应症
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
- •Patients will be enrolled at Visit 1 into the run-in period if they meet all the following criteria: 1. Men or post-menopausal women that express their willing to participate in the study by signing the informed consent; 2. Subjects aged 40-69 years (inclusive); 3. Medical history of arterial hypertension not controlled with ACE-inhibitors given as monotherapy. 4. Subjects satisfying any 3 of the following 5 criteria of metabolic syndrome, defined according to the criteria of the American Heart Association (Grundy et al, 2005): Elevated waist circumference (≥ 102 cm in men and ≥ 88 cm in women); Elevated triglycerides (≥ 150 mg/dl): Reduced HDL cholesterol (< 40 mg/dl in men and < 50 mg/dl in women); Elevated blood pressure (SBP ≥ 130 mmHg or DBP ≥ 85 mmHg); Elevated fasting plasma glucose (FPG ≥ 100 mg/dl) or drug treatment for elevated glucose levels; 5. Patient?s co-operative attitude and able to adhere to study protocol procedures and timelines. At visit 2 (end of run-in), after 4 weeks of treatment with Enalapril 20 mg once daily, patients will be randomised in the treatment phase if they meet the following criteria: 6. SBP 140-159 mmHg and DBP 90-99 mmHg.
- •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
- •Patients will not be enrolled at Visit 1 into the run-in period if they meet any of the following criteria: 1. History of major cardiovascular events (i.e. myocardial infarction, angina, congestive heart failure) or cerebrovascular events (stroke, transient ischemic attacks); 2. Clinically significant cardiac arrhythmias (e.g. atrial fibrillation, atrial-ventricular block); 3. Blood creatinine levels > 1.2 mg/dl in women or > 1.3 mg/dl in men; 4. Albumin/Creatinine ratio in urines > 300 mg/g; 5. Concomitant diabetes mellitus (i.e. FPG > 126 mg/dl) or concomitant oral antidiabetic therapy; 6. Concomitant dyslipidemias treated with statines therapy; 7. Severe anaemia, defined as haemoglobin levels ≤ 10 g/dl; 8. History of other clinically significant cardiac, renal, neurologic, hepatic or endocrine diseases whose sequelae and/or treatments could interfere with the results of the present study; 9. Any other clinically significant abnormalities, as judged by the Investigator, in laboratory tests (haematology, blood chemistry) performed at the screening visit; 10. History of malignancy in the past 3 years; 11. History of alcohol or drug abuse; 12. Allergy, sensitivity or intolerance to study drug and/or study drug formulation ingredients; 13. Patients with metabolic or major psychiatric disorders that, in the view of the investigator, could compromise the patient?s participation in the study; 14. Patients unable to give a valid informed consent; 15. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 16. Patients who received any investigational new drug within the last 12 weeks; 17. Patients who have been previously enrolled in this study; 18. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
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