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临床试验/NCT02710552
NCT02710552Unknown4 期

Randomized Comparison of Fixed Low-dose Combination of THREE Antihypertensive Drugs Versus Fixed High-dose Combination of Two Antihypertensive Drugs in Arterial Hypertension (the 3D 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

The aim of the study is to compare the efficacy and safety of low-dose combination of three antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in arterial hypertension

详细描述

The aim of the study is to compare the efficacy and safety of commercially available low-dose combination of three antihypertensive drugs versus commercially available fixed high-dose combination of two antihypertensive drugs in arterial hypertension

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
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

Three antihypertensive Drugs

Active Comparator

Patients will be treated with Tripliam, that is a commercially available fixed low-dose combination of three antihypertensive drugs, that is 5 mg/daily perindopril, 1,25 mg/daily indapamide and 5 mg/day amlodipine

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

Two antihypertensive drugs

Active Comparator

Patients will be treated with Reaptan, that is a commercially available fixed high-dose combination of two antihypertensive drugs, that is 10 mg/daily perindopril and 5 mg/day amlodipine

干预措施: Reaptan (perindopril, 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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