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临床试验/NCT03267329
NCT03267329已完成4 期

A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Evaluate the Central Aortic Pressure Effect Between Fixed Dose Combination (Duowell® Tab) and Monotherapy of Telmisartan in Mild Dyslipidemia Patients With Hypertension

Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年9月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Changes from baseline in mean central systolic blood pressure

研究概览

简要总结

This study is to evaluate effect and safety on central blood pressure with Duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Duowell® Tab.

Experimental

Once daily during 16 wks

干预措施: Duowell® (Drug)

Telmisartan

Active Comparator

Once daily during 16 wks

干预措施: Telmisartan (Drug)

结局指标

主要结局

Changes from baseline in mean central systolic blood pressure

时间窗: at week 16

次要结局

  • Changes from baseline in mean brachial systolic blood pressure(at week 4 and at week 16 and at week 28)
  • Changes from baseline in carotid femoral pulse wave velocity(at week 16 and at week 28)
  • Changes from baseline in mean brachial pulse pressure(at week 4 and at week 16 and and at week 28)
  • Changes from mean brachial diastolic blood pressure(at week 4 and at week 16 and at week 28)
  • Changes from baseline in augmentation index(at week 16 and at week 28)

研究者

发起方
Yuhan Corporation
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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