Bisoprolol Monotherapy Versus Valsartan-Amlodipine for Hypertension Management in Adults Younger Than 60: Results of a Randomized Triple-Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- mean blood pressure
研究概览
简要总结
Randomized comparison of bisoprolol 2.5 mg monotherapy with fix combination drug valsartan 80 mg- amlodipine 5 mg
详细描述
In this randomized, triple-blind, two-arm clinical trial, 59 adults aged 18-60 years with newly diagnosed stage 1-2 hypertension were assigned to bisoprolol 2.5 mg once daily (n=30) or a valsartan 80 mg + amlodipine 5 mg single-pill combination (n=29) for two months. Blood pressure was assessed using 24-hour ambulatory monitoring at baseline and after treatment. Statistical analysis included paired t-tests, ANOVA, and nonparametric methods, with significance set at p<0.05.
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
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed stage 1 or stage 2 hypertension confirmed by 24-hour ambulatory blood pressure monitoring (ABPM).
排除标准
- •Severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
- •Contraindications to beta-blockers
- •Contraindication to calcium channel blocker
- •Contraindication to angiotensin receptor blockers
- •Significant comorbidities requiring specific therapy such as diabetes or chronic heart failure, or current use of medications that could interact with the study drugs were excluded
- •Pregnant or breastfeeding women
- •Individuals with suspected secondary hypertension, and those unable to adhere to follow-up procedures
研究组 & 干预措施
bisoprolol
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol
干预措施: Bisoprolol (Drug)
Valsartan- Amlodipine fix dose combination
Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-Amlodipine
干预措施: valsartan and amlodipine (Drug)
结局指标
主要结局
mean blood pressure
时间窗: 2 months
mean blood pressure derived from 24 hours holter monitoring
mean blood pressure nighttime
时间窗: 2 months
mean blood pressure at nighttime derived from 24 hours holter monitoring
次要结局
- drug adverse effect(2 months)
研究者
Javad Kojuri
professor
Shiraz University of Medical Sciences