NCT00241124已完成4 期
A Randomized, Double Blind, Double Dummy, Parallel Group, Active-Controlled Study To Evaluate The Effectiveness Of Morning Versus Evening Doses Of 320 Mg Valsartan Versus 40 Mg Lisinopril On The 24 Hour Blood Pressure Profile In Patients With Hypertension And Non-Insulin Dependent Diabetes
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
- 1,099
- 试验地点
- 1
- 主要终点
- Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks
研究概览
简要总结
A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Hypertension defined by a MSSBP >=150 mmHg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. MSSBP >140 mmHg)
- •Randomisation mean 24h blood pressure above 130/80 mmHg
- •In addition the patients must fulfill, at least, one of the following criteria:
- •Controlled type II Diabetes mellitus Hypercholesteremia, currently treated with lipid-lowering drugs Metabolic syndrome MI, CABG or PTCA more than one year ago Stroke or transient ischemic cerebral attack more than one year ago Documented history of peripheral vascular disease, increased IMT, or carotid plaques Documented history of LVH Elderly >65 years
排除标准
- •- MSSBP >=180 mmHg and/or MSDBP >= 110 mmHg at any time from Visit 1 to Visit 3
- •Inability to discontinue all prior anti-hypertensive medications safely for a period of three weeks
- •Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks
Change from baseline in systolic 24 hour blood pressure after 12 weeks
次要结局
- Change from baseline manual blood pressure and pulse pressure after 26 weeks
- Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks
- Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks
- Change from baseline heart size after 26 weeks
- Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks
研究者
研究点 (1)
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