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临床试验/NCT00171327
NCT00171327已完成4 期

Efficacy and Safety of Fluvastatin 80 mg or Valsartan 160 mg and Their Combination in Dyslipidemic Patients With Arterial Hypertension and Endothelial Dysfunction

Novartis2 个研究点 分布在 2 个国家目标入组 213 人开始时间: 2004年7月1日最近更新:
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
213
试验地点
2
主要终点
Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks

研究概览

简要总结

Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.

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
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arterial hypertension
  • Dyslipidemia
  • Cholesterol lowering diet

排除标准

  • Constant antihypertensive treatment
  • Diabetes mellitus
  • Myocardial infarction or stroke in the previous 3 months
  • Other inclusion and exclusion criteria may apply

结局指标

主要结局

Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks

Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks

次要结局

  • Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides
  • Evaluating blood pressure effect on endothelial function
  • Evaluating total cholesterol effect on endothelial function

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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