NCT00394745已完成3 期
A 12 Week Treatment, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Valsartan 160-320 mg With Regard to Effects on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.
研究概览
简要总结
The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients >= 18 years of age at Visit 1
- •Hypertension (systolic blood pressure >= 140 mmHg and < 170 mmHg and/or diastolic blood pressure >= 90 mmHg and < 105 mmHg
- •Elevated triglycerides
- •Metabolic syndrome as defined by Adult Treatment Panel III criteria
排除标准
- •MSSBP >= 170 mmHg and/or MSDBP >= 105 mmHg at any time between Visit 1 and Visit 2
- •Diabetes mellitus
- •Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1
- •A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.
次要结局
- To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.
- To assess the safety and tolerability of valsartan 160-320mg.
- To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
研究者
研究点 (2)
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