NCT00325806已完成4 期
Prevention of Hypertension in Patients With High-Normal Blood Pressure With the Angiotensin-Converting-Enzyme-Inhibitor Ramipril - a Randomised Prevention Trial of the German Hypertension League.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,008
- 主要终点
- Mean systolic and diastolic 24-hour blood pressure in ABPM
研究概览
简要总结
Primary objective:
Mean values of systolic and diastolic office blood pressure
Secondary objectives:
Total mortality, occurrence of cardio- and cerebrovascular events, change of mean blood pressure (ABPM : Ambulatory Blood Pressure Monitoring) during the observation
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no previous antihypertensive therapy
- •high-normal blood pressure according to the JNC-VI definition (systolic 130 - 139 and/or diastolic 85 - 89 mmHg)
排除标准
- •antihypertensive therapy
- •blood pressure greater 140/90 mmHg or ABPM greater 135/85 mmHg
结局指标
主要结局
Mean systolic and diastolic 24-hour blood pressure in ABPM
次要结局
- Overall mortality and total number of cardiovascular and cerebro-vascular events
- Changes in mean blood pressure readings over time
- Reasons for admissions to hospital/-stays
- Occurrence of pathological fasting glucose levels in serum/pathological HbA1c levels.
研究者
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Study of the efficacy of two blood pressure lowering drugs, ramipril and nifedipine GITS, in reducing the variability of blood pressure in patients with high blood pressure.essential hypertensionMedDRA version: 17.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2014-003459-76-ITIstituto Auxologico Italiano, IRCCS168