NCT00171093已完成3 期
A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia
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
- 369
- 试验地点
- 2
- 主要终点
- Change in average ambulatory systolic blood pressure over 24 hours
研究概览
简要总结
This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..
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
- •ESSENTIAL HYPERTENSION
- •ELEVATED LDL-C CHOLESTEROL
- •USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS
排除标准
- •SEVERE HYPERTENSION
- •EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
- •HISTORY OF STROKE OR MYOCARDIAL INFARCTION
- •DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
- •UNCONTROLLED DIABETES OR INSULIN
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change in average ambulatory systolic blood pressure over 24 hours
Change in serum low density lipoprotein cholesterol (LDL-C )
次要结局
- Adverse events and serious adverse events at each study visit for 42 days
- Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
- Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
- Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
- Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days
研究者
研究点 (2)
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