NCT01748253Unknown不适用
ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing
Acrobat Trial Group1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in 24-hour average blood pressure from baseline to Week 12.
研究概览
简要总结
Evaluation of 24-hour antihypertensive effect of long-acting ARB-CCB tablet administrated to hypertensive patients with atrial fibrillation, and comparison of 24-hour antihypertensive effect of long-acting ARB-CCB tablet between morning administration and bedtime administration.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients who meet the following conditions:
- •Patients who meet any of the following standards of blood pressure after administration of 40 mg/day telmisartan or 5 mg/day amlodipine for 4 weeks:
- •Blood pressure at hospital visit: Systolic blood pressure is 140 mmHg or higher, and/or diastolic blood pressure is 90 mmHg or higher.
- •(average of 3 measurements obtained at a scheduled visit)
- •Blood pressure at home: Systolic blood pressure is 135 mmHg or higher, and/or diastolic blood pressure is 85 mmHg or higher.
- •(average of measurements for the 5 days prior to drug assignment [4 measurements per day in total: 2 in the morning and 2 before bedtime])
- •Patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
- •Age: 20 years old or older (at time of informed consent)
- •Sex: male or female
- •Clinical classification: Outpatient
- •Patients who give written consent of agreement to voluntarily participate in the clinical study.
排除标准
- •Patients with serious liver and/or kidney disease
- •Patients with history of allergy to telmisartan or amlodipine
- •Patients receiving antihypertensives other than telmisartan or amlodipine during observation period
- •Patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
- •Patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
- •Patients with average systolic blood pressure at hospital visit higher than 180 mmHg during observation period.
- •Patients with New York Heart Association (NYHA) class III-IV heart failure, patients with heart failure requiring hospitalization, or patients with poor left ventricular function.
- •Patients who have stroke or cardiac infarction within 6 months before giving consent.
- •Patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including PCI).
- •Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
- •In addition, patients who are determined as not eligible by their study doctor.
研究组 & 干预措施
Telmisartan-amlodipine tablet administration group (morning)
Active Comparator
干预措施: Telmisartan-amlodipine tablet administration group (morning) (Drug)
Telmisartan-amlodipine tablet administration group (bedtime)
Active Comparator
干预措施: Telmisartan-amlodipine tablet administration group (bedtime) (Drug)
结局指标
主要结局
Change in 24-hour average blood pressure from baseline to Week 12.
时间窗: Baseline and 12 weeks.
次要结局
- Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.(Baseline and 12 weeks.)
- Change in blood pressure at hospital visit from baseline to Week 12.(Baseline and 12 weeks.)
- Change in blood pressure at home from baseline to Week 12.(Baseline and 12 weeks.)
- Change in blood pressure control rate from baseline to Week 12.(Baseline and 12 weeks.)
- Change in blood pressure variability from baseline to Week 12.(Baseline and 12 weeks.)
- Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.(Baseline and 12 weeks.)
- Onset of Adverse events(Baseline and 12 weeks.)
- Onset of atrial fibrillation(Baseline and 12 weeks.)
- Pulse rate(Baseline and 12 weeks.)
- PWV value(Baseline and 12 weeks.)
- Clinical laboratory test results(Baseline and 12 weeks.)
研究者
研究点 (1)
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