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临床试验/NCT02710539
NCT02710539Unknown4 期

Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
100
试验地点
1
主要终点
Number of patients who reach target blood pressure

研究概览

简要总结

Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension

详细描述

The aim of this randomized study is to compare a once-daily fixed combination pill with a free-drug combination of three antihypertensive agents in arterial hypertension

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with arterial hypertension resistant to monotherapy

排除标准

  • 未提供

研究组 & 干预措施

Free combination

Active Comparator

Perindopril 10 mg/daily, indapamide 2,5 mg/daily, and amlodipine 10 mg/daily will be given according to a free combination strategy

干预措施: perindopril, indapamide , amlodipine (Drug)

Tripliam

Active Comparator

fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily

干预措施: Tripliam (perindopril, indapamide, amlodipine) (Drug)

结局指标

主要结局

Number of patients who reach target blood pressure

时间窗: From baseline to the end of the 3-month study period

How many patients have blood pressure within normal limits

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pelliccia

Assistant Professor

University of Roma La Sapienza

研究点 (1)

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