NCT00171756已完成4 期
A Double-blind, Double-dummy, Multi-centre, Randomized, Active Controlled, Parallel Group Pilot Trial to Compare the Effects of Valsartan and Atenolol on the Pro-thrombotic State in Patients With Mild to Moderate Hypertension.
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
- 92
- 试验地点
- 1
- 主要终点
- Change from baseline in a clinical laboratory measurement of a blood clotting factor after 12 weeks
研究概览
简要总结
A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 18 - 75 years of age inclusively.
- •Mild to moderate hypertension (MSDBP >= 95 and >= 110 mmHg and / or MSSBP >140mm Hg) at visit 1, requiring pharmacological intervention. For newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. In addition, patients must require therapy despite having been following dietary & lifestyle advice for at least 3 months.
- •Written informed consent to participate in the study, prior to any study procedures.
- •Ability to communicate and comply with all study requirements
排除标准
- •o Uncontrolled hypertension defined as seated blood pressure of either systolic BP >180 mmHg and/or diastolic BP >110mmHg.
- •Clinically significant laboratory abnormalities that may interfere with the assessment of safety and/or efficacy of the study drug
- •Patients with severe medical condition(s) that in the view of the investigator may prohibit participation in the study
- •Renal artery stenosis
- •Diabetes Mellitus
- •Any condition resulting from or leading to platelet or clotting abnormalities (eg. hemophilia, von Willebrand's disease).
- •History of a vascular event or intervention (e.g. MI, PTCA or CABG) within 6 months preceding the study.
- •History of clinically significant angina, LVH, transient ischemic attack, stroke, intermittent claudication, deep vein thrombosis (DVT), pulmonary embolism or peripheral vascular disease.
- •Uncontrolled atrial fibrillation (>100 b.p.m. at rest) or other conditions which may require anti-aggregant or anti-vitamin K therapies.
- •Clinical evidence of congestive heart failure.
- •Evidence of second or third degree heart block or sick sinus syndrome.
结局指标
主要结局
Change from baseline in a clinical laboratory measurement of a blood clotting factor after 12 weeks
次要结局
- Change from baseline in clinical laboratory measurements of blood clotting factors, including platelet activation, thrombosis, fibrinolysis, anticoagulation after 12 weeks
- Blood pressure of 140/85 mmHg or lower after 12 weeks
研究者
研究点 (1)
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