Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Changes in 24 Hour Systolic Blood Pressure
研究概览
简要总结
A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control.
To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.
详细描述
The identification of any significant difference could lead to more effective therapeutic management of arterial hypertension, which in turn would result in a reduced cardiovascular burden, lower costs and a better quality of life for hypertensive patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian patients aged 18-80 years;
- •History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months.
排除标准
- •BP levels > 150/90 mmHg or < 115/75 mmHg in the last 3 months.
- •Postural hypotension, defined as symptoms resulting from a > 20 mm Hg drop of systolic BP or a > 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position.
- •Known Extreme dippers at baseline (fall of mean night time SBP > 20% of mean day time SBP)
- •Individuals with jobs which require night-time shift work.
- •Pregnant women or those planning to become pregnant.
研究组 & 干预措施
Evening medication
Anti hypertensive medication in the evening (between 18.00 and 23.00)
干预措施: Anti-hypertensive Medication - (Drug)
Morning medication
Antihypertensive medication in the morning(between 06.00 and 11.00)
干预措施: Anti-hypertensive Medication - (Drug)
结局指标
主要结局
Changes in 24 Hour Systolic Blood Pressure
时间窗: 6 months
Changes in 24 hour systolic Blood Pressure using ABPM
次要结局
- Mean Clinic - Systolic BP(6 months)
- Mean Clinic - Diastolic BP(6 months)
- Mean Day-time ABPM Systolic BP(6 months)
- Mean Day-time ABPM Diastolic BP(6 months)
- Μean Night Time ABPM Diastolic BP(6 months)
- Quality of Life Score(6 months)
- Μean Night Time ABPM Systolic BP(6 months)
- Self Reported Side Effects(12 months)