EUCTR2005-001578-28-EE进行中（未招募）不适用
Comparison the effects of Nebivolol versus Metoprolol succinate on endothelial function and large artery stiffness.A parallel group, randomized, double-blind, active control phase IV clinical trialNEMENDAS - NEMENDAS
Berlin-Chemie AG Menarini Group0 个研究点目标入组 80 人开始时间: 2005年11月11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
- 入组人数
- 80
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 with mild to moderate essential hypertension (systolic BP 140-179 mmHg and/or diastolic BP 90-109 mmHg)*
- •-Male and female patients aged 30-65 years
- •* Newly diagnosed untreated patients or previously diagnosed patients who were without treatment at least two weeks prior to screening* If patient has been taken previously antihypertensive medication the BP values are originated after untreated two weeks before randomization
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Concomitant medication: Cyclic antidepressants, MAO inhibitors, corticosteroids
- •-Diabetes I or II typus (fasting venous plasma glucose > 6.4 mmol/l)
- •-Bronchial asthma and chronic obstructive airway disease
- •-Body mass index > 30 kg/m2
- •-Ischaemic heart disease (III, IV stage, Canadian Cardiovascular Society)
- •-Clinically relevant heart failure (NYHA class II - IV
- •-Clinically relevant valve disease (physical examination)
- •-Arrhytmias and conduction disturbances, requiring therapy, sinus bradycardia at rest < 50 b/min, sick sinus syndrome, AV - block stage II – III
- •-Secondary hypertension (urea >8.3 mmol/l, creatinine >120µmol/l (males), >103 µmol/l (females), TSH > 4.0mIU/l, free T4 > 27 pmol/l)
- •-Clinically relevant atherosclerotic disease of lower extremities
- •-Acute inflammation (according to CRP > 10mg/l)
- •-Hypercholesterolemia (> 6,5 mmol/l)
- •-Allergic reaction to ?-blockers
- •-Pregnant or breast-feeding women
- •-History of hepatic, renal, metabolic or endocrine diseases
- •-Smoking > 10 cigarettes per day
- •-Alcohol consumption > 7 drinks per week (drink = 0,33 l beer, 120 ml wine or 30 ml strong alcoholic drink)
- •-The patient has had surgery or disease of the gastrointestinal tract which, in the opinion of the investigator, may influence the absorption or elimination of the study drug
- •-The patient has a severe organic disorder that may interfere with the absorption, pharmacokinetics, or elimination of the study medication.
- •-The patient has a comorbid condition that would be expected to result in death during the trial period (e.g., terminal cancer, AIDS)
- •-The patient has chronic psychoses or behavioural conditions that would limit the ability of the patient to comply with the requirements of this study
- •-The patient has known hypersensitivity to Nebivolol, Metoprolol or hydrochlorothiazide related compounds
- •-Patient is enrolled in another clinical trial.
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