NCT00241150已完成4 期
A Multicenter, Double Blind, Randomized Study With Two Parallel Groups Comparing The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 80
- 主要终点
- Change in baseline flow-mediated vasodilatation after 12 weeks
研究概览
简要总结
A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).
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
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet the following inclusion criteria at Visit 1, Visit 2 and Visit
- •Inclusion criteria for Group A (overweight postmenopausal females with high-normal blood pressure/ mild Stage I hypertension)
- •Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.
- •Mean blood pressure between 130 - 149 mm Hg systolic and/or 85 - 94 mm Hg diastolic
- •When systolic blood pressure and diastolic blood pressure fall into different categories (high normal versus mild stage I hypertension), the higher category should be selected to classify or group the subject.
- •Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
- •Subjects who agree not to alter their diet or exercise routine during the study and comply with study specific restrictions 24 hours prior to the next scheduled study visit
- •Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study
排除标准
- •1. Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.
- •2. Mean blood pressure between 90 - 129 mm Hg systolic and/or 50 - 84 mm Hg diastolic.
- •3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
结局指标
主要结局
Change in baseline flow-mediated vasodilatation after 12 weeks
次要结局
- Change in baseline brachial artery flow after 12 weeks
- Adverse events and serious adverse events at each study visit for up to 12 weeks
- Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks
- Hematology, blood chemistries, and urine for up to 12 weeks
- Vital signs, physical condition, and body weight for up to 12 weeks
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