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临床试验/NCT02901977
NCT02901977已完成4 期

On the Antithrombotic Effects of Doxazosin and Ramipril in Essential Hypertension

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
71
试验地点
1
主要终点
Thrombin generation

研究概览

简要总结

Randomized double-blind parallel group study in patients with mild-to-moderate hypertension to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.

详细描述

This study aims to answer the following questions: 1) Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension? 2) Are the potential antithrombotic effects of doxazosin different to the effects of an ACE inhibitor? 3) Is there a relation between the antihypertensive effect and the antithrombotic effect of these antihypertensive agents?

The co-primary outcomes are changes in endothelial function assessed by flow mediated vasodilatation, and in haemostatic function measured by the generation of thrombin-antithrombin complex.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary mild-to-moderate hypertension

排除标准

  • Pregnancy and lactation
  • Recent (6 months) malignant disease or ongoing treatment for malignancy
  • No absolute indication or contraindication for any of the study drugs

研究组 & 干预措施

ACE inhibitor

Experimental

Ramipril tablets 10 mg od for 12 weeks

干预措施: Ramipril (Drug)

Alpha receptor blocker

Active Comparator

Doxazosin tablets 8 mg od for 12 weeks

干预措施: Doxazosin (Drug)

结局指标

主要结局

Thrombin generation

时间窗: 12 weeks

Thrombin-Antithrombin complex (TAT)

Endothelial function

时间窗: 12 weeks

Forearm post-ischemic flow mediated dilatation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Kahan

Principal investigator, Professor

Karolinska Institutet

研究点 (1)

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