EUCTR2010-022232-37-IT进行中(未招募)不适用
Effects of a combination treatment with lercanidipine + enalapril vs. lercanidipine + hydrochlorothiazide on blood pressure and endothelial function in essential hypertensive patients - enalerca
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA0 个研究点开始时间: 2011年2月7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
- •Hypertension is defined as a mean lying systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg at the screening visit, both in never patients and in those previously treated (non responders). Hypertension will be considered essential if there is no evidence of an underlying treatable cause after suitable clinical and laboratory assessment. Hypertension will be considered essential if there is no evidence of an underlying treatable cause after suitable clinical and laboratory assessment. • The mean systolic and diastolic blood pressures are defined as the arithmetic mean of 3 consecutive readings taken at 1 minute intervals after 5 minutes of repose. • Age range: 30-70 years. Only postmenopausal women will be included. • Signed Informed Consent obtained by patient
- •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
- •Severe hypertension (systolic blood pressure = 180 mm Hg, diastolic blood pressure =110 mm Hg). • Secondary hypertension (Renovascular hypertension, aortic coarctation, primary aldosteronism, phaeochromocytoma, etc.) • Hypersensibility, allergy or contraindication to the use of ACE inhibitors, calcium channel blockers, diuretics. • Cerebrovascular accident or transient ischemic attacks in the last 6 months. • Angina pectoris, Myocardial infarction; percutaneous coronary angioplasty or coronary artery bypass surgery, heart failure NYHA II-IV within last 6 months. • Clinically significant AV conduction disturbances and/or arrhythmias (e.g. second- or third-degree AV block; Sick-sinus syndrome or clinically significant bradycardia- resting heart rate < 45 beats/minute) • Presence or known history of hemodynamically significant obstructive valvular disease or hypertrophic cardiomyopathy • Clinically significant supraventricular or ventricular arrhythmias • Concomitant diabetes mellitus (fasting glucose > 126 mg/dl, or current treatment for diabetes) • Severe renal failure (creatinine clearance <30 ml/min). • Severe liver failure • Any other concurrent severe disease which could preclude participation or survival (according to the physician’s judgment). • Malignant neoplasms in the last 5 years (apart from skin cancer different from melanoma) • Use of other antihypertensive drugs apart from what reported in the protocol, cyclosporine, grapefruit juice, dugs inhibiting CYP3A4. • Patients who are currently abusing or previously abused alcohol or other drug substances (within past two years). • Patients participating in other clinical trials in the previous 30 days.
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