临床试验/NCT01835418

NCT01835418Unknown不适用

Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial

Allina Health System0 个研究点目标入组 100 人开始时间: 2013年4月最近更新: 2013年4月19日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Allina Health System
入组人数: 100
主要终点: Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study seeks to compare the differences in effectiveness among individual patients treated at for hypertension with bedtime administration of amlodipine versus lisinopril. There will be an analysis of whether one medication was more effective than another and whether specific patient factors could predict who responded better to which one.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
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: 否

入选标准

•Age 40 to 80
•Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.
•Minimum Asleep SBP mean of ≥ 120mmHg for inclusion.

排除标准

•Current antihypertensive medication use
•Baseline GFR < 45
•Preexisting macroproteinuria
•Chronic congestive heart failure
•History of CVA
•Diabetes Mellitus
•Pregnancy
•Night-shift work
•Other preexisting contraindication to amlodipine or lisinopril

研究组 & 干预措施

Lisinopril

Experimental

bedtime administration of lisinopril 20mg

干预措施: Amlodipine (Drug)

Amlodipine

Experimental

Bedtime administration of amlodipine 5mg

干预措施: Amlodipine (Drug)

结局指标

主要结局

Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril

时间窗: 1 year

次要结局

Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP(1 year)
Impact of individual medications on sleep-time blood pressure drop (dipping status)(1 year)
Association of baseline renin levels to sleep-time blood pressure drop(1 year)
Association of baseline renin levels with response to amlodipine versus lisinopril(1 year)
Association of baseline dipping status with response to amlodipine versus lisinopril(1 year)
Association of age and response to amlodipine versus lisinopril(1 year)

研究者

发起方

Allina Health System

申办方类型

Other

责任方

Principal Investigator

主要研究者

David Ingham

Physician

Allina Health System

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