Comparative Analysis of Valsartan 80 mg and Amlodipine 5 mg in Fixed-Dose Combination Therapy Versus Combination Free Drug Therapy for Ambulatory Blood Pressure Management: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Mean 24 hours systolic blood pressure
研究概览
简要总结
Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.
详细描述
Patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications.
This study used the permutation block randomization method (block size = 4) for the randomization process.Patients were randomly assigned to either the FDC group or the free equivalent combination group.
Eligible patients underwent an 8-week period during which they received either Valsartan 80 mg and Amlodipine 5 mg as an FDC or as free equivalent combinations. The FDC group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and Valsartan in the evening). 24-hour ambulatory blood pressure monitoring (ABPM) at the time of inclusion and at the end of the 8-week period were performed using a standard ABPM device that the patients wore with an appropriately sized cuff.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications
排除标准
- •Patients previously been on antihypertensive drugs
- •Patients had secondary high blood pressure
- •Patients had severe high blood pressure (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg)
- •Patients had ischemic heart disease in the past
- •Patients were unable to receive any part of the treatment
- •Patients who refuse to take part in study
研究组 & 干预措施
valsartan- Amlodipine fix dose combination pill
Patients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill
干预措施: valsartan-amlodipine 80/5 mg FDC (Drug)
Valsartan- Amlodipine free dose combination
Patients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately
干预措施: valsartan 80 mg and amlodipine 5 mg as free combination (Drug)
结局指标
主要结局
Mean 24 hours systolic blood pressure
时间窗: 8 weeks
The average systolic blood pressure over 24 hours, during the day and at night
Mean 24 hours diastolic blood pressure
时间窗: 8 weeks
The average diastolic blood pressure over 24 hours, during the day and at night
Mean 24 hours mean blood pressure
时间窗: 8 weeks
The average mean blood pressure over 24 hours, during the day and at night
次要结局
- Dipping(8 weeks)
研究者
Javad Kojuri
professor
Shiraz University of Medical Sciences