NCT00385931已完成3 期
A Multi-centre Study to Evaluate the Effects of Valsartan and the Combination of Valsartan and Simvastatin on Blood Pressure (Ambulatory and Std Cuff) and on Biochemical Markers of Endothelial Function (hsCRP, MCP-1, Serum F2 Isoprostanes, PAI-1, tPA, PICP, PIIINP, MMP9, MMP1, TIMP 1), Safety and Tolerability
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
- 412
- 试验地点
- 2
- 主要终点
- Change from baseline in ambulatory systolic blood pressure at 12 weeks
研究概览
简要总结
This study will assess and compare the efficacy and safety of valsartan and the combination of valsartan and simvastatin in patients with high blood pressure and high cholesterol.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients at least 50 years of age
- •Mild to moderate essential systolic hypertension (grades 1 and 2 WHO classification) defined as MSSBP ≥ 150 mmHg and <180mmHg
- •Simultaneous primary hypercholesterolemia or mixed dislipidemia (Fredrickson Types IIa and IIb) defined by LDL-C level ≥ 130 mg/dL and <190 mg/dL and triglyceride levels ≤ 400 mg/dL despite dietary therapy
- •Off medication at randomization
排除标准
- •Severe hypertension (grade 3 WHO classification
- •≥ 180 mm Hg systolic or ≥ 110 mm Hg (diastolic)
- •secondary form of hypertension
- •known Keith-Wagener Grade III or IV hypertensive retinopathy
- •history of hypertensive encephalopathy or cerebrovascular accident within the preceding 12 months
- •transient ischemic cerebral attack during the preceding 6 months
- •dyslipidemia secondary to other causes
- •Type 1 diabetes mellitus
- •Type 2 diabetes mellitus with poor glucose control
- •history of systemic inflammatory diseases
- •serum CK more than twice ULN
- •sodium depletion
- •malignancy in preceding 5 years history of heart failure
- •myocardial infarction within the preceding 12 months
- •second or third degree heart block
- •concomitant refractory angina pectoris
- •symptomatic arrhythmia
- •valvular heart disease
- •Any condition/surgery that may alter absorption, distribution, metabolism, excretion of any drug (e.g. history of major gastrointestinal tract surgery, inflammatory bowel syndrome, pancreatic dysfunction, impaired renal or liver function)
结局指标
主要结局
Change from baseline in ambulatory systolic blood pressure at 12 weeks
次要结局
- Change from baseline at 12 weeks for ambulatory diastolic blood pressure, systolic and diastolic blood pressure (std cuff), day and nighttime blood pressures, biochemical markers of endothelial function & lipid levels
- Safety and tolerability
研究者
研究点 (2)
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