EUCTR2010-018639-17-DE进行中（未招募）1 期
Prospective and open label study with blind end point evaluation on the effect of mineralcorticoid receptor inhibition on endothelial function of the micro- and macrovasculature in patient with metabolic syndrome
niversity Hospital Erlangen0 个研究点目标入组 42 人开始时间: 2010年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- Male
入选标准
- •Male patients aged > 18 years
- •with mild uncomplicated primary arterial hypertension with a mean sitting SPB = 130 mmHg or DBP = 85 mmHg or treated hypertension and
- •at least 2 of the following traits of the metabolic syndrome (ATP III criteria):
- •abdominal obesity (abdominal girth = 88 cm in females and = 102 cm in males),
- •triglyceride level = 150 mg/dL or treatment for elevated triglyzerides,
- •HDL < 40 mg/dL for men and < 50 mg/dL for women or treatment for low HDL
- •fasting blood glucose = 100 mg/dL and = 126 mg/dl.
- •Written informed consent
- •Agreement to attend all study visits as planned in the protocol
- •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 with or without antihypertensive therapy and average blood pressure > 160/100 mmHg
- •Patients with secondary hypertension
- •Patients with one antihypertensive agent maximally dosed or two (or less) agents with half (or less) of maximum approved dose
- •Patients with diabetes mellitus type 1 or type 2
- •Smokers and ex-smokers < 1 year
- •Female patients (to prevent effects of changes in endothelial function attributable to the menstrual cycle)
- •Patients with sick sinus syndrome
- •Patients with higher degree of sinoatrial or atrioventricular block (II-III?)
- •Patients with bradycardia (< 50 beats/min)
- •Patients with malignant arrhythmias
- •Patients with known cardiovascular, disease
- •Patients with known cerebrovacular disease
- •Patients with peripheral occlusive artery disease
- •Patients with history of epilepsy
- •Patients with severe hepatic disease (serum GOT, GPT, ?-GT, AP, bilirubin > 300 of uppper normal range)
- •Patients with renal disease defined by eGFR < 60 ml/min/1,73m2
- •Patients with history of malignant disease within the last 2 years
- •Patients with history of depression
- •Patients with drug or alcohol abuse
- •Use of any investigational drug within 28 days before study entry
- •Known allergy or a known intolerance to the study drug
- •Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol, especially likelihood of the need for additional antihypertensive medication
- •Serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases
- •Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
- •Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
研究者
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