NCT00529750已完成4 期
Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 108
- 主要终点
- Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.
研究概览
简要总结
Primary:
- To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.
Secondary:
- To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome.
- To correlate the oxidative stress status with endothelial function in these patients.
- To evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function .
- To correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hypertension grade 1 or 2
- •With at least two of the following criteria for the diagnosis of metabolic syndrome:
- •Body mass index > or = 25 kg/m2 AND waist circumference > or = 100 cm.
- •Dyslipidemia (triglycerides fasting serum levels > or = 200 mg/dL OR HDL serum levels < or = 40 mg/dL)
- •Fasting serum glucose > or = 110 mg/dL but < 126 mg/dL
排除标准
- •Known hypersensitivity to Irbesartan
- •Hypertension grade 3
- •History of clinical vascular events such as TIAs, stroke, peripheral arterial disease
- •Coronary artery disease
- •Renal insufficiency (creatinine serum levels > or = 1.2 mg/dL)
- •Presence of clinical heart failure
- •Asthma and COPD
- •Valvular cardiopathy clinically relevant
- •Current therapy with antioxidant drugs, statins
- •Therapy with AIIRA for at least 3 months during the last semester
- •Presence of any acute illness or major trauma in the last 8 weeks
- •History of a chronic inflammatory disease such as rheumatoid arthritis, immune disorders or connective tissue disease.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Irbesartan Group
Experimental
150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks
干预措施: IRBESARTAN (Drug)
Atenolol Group
Active Comparator
50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.
干预措施: Atenolol (Drug)
结局指标
主要结局
Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.
时间窗: at baseline and at the end of the study-12th wk
次要结局
未报告次要终点
研究者
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