Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients (CREATIVE Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment
研究概览
简要总结
This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in subjects with mild to moderate primary hypertension.
详细描述
Primary objectives:
To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory DBP as compared with metoprolol SR in the last 4 hours after 12-week active treatment in subjects with mild to moderate essential hypertension (EH).
Secondary objectives:
- To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at different times (Example: blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among subjects with mild to moderate EH
- To evaluate safety of the two drugs
- To evaluate the treatment compliance of the two drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged: >=18 years and =<70 years old
- •EH who are suitable for mono-therapy, either mild to moderate EH patients who have not been treated with anti-hypertension drugs, or mild EH subjects who have taken anti-hypertension drug.
- •Clinic resting Heart Rate >=70 beats per minute (bpm)
- •Patients who have signed informed consent
排除标准
- •Subjects with contraindications according to the China Summary of Product Characteristics (SmPCs) of both bisoprolol and metoprolol SR, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), sick sinus syndrome, symptomatic bradycardia or symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc.
- •Moderate EH patients who have used anti-hypertension drugs
- •Secondary hypertension
- •Subjects with history of coronary heart disease
- •Chronic or acute heart failure
- •Cerebrovascular events within 6 months before screening
- •Impaired hepatic or renal function (according to local lab standard)
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Bisoprolol
干预措施: Bisoprolol (Drug)
Metoprolol
干预措施: Metoprolol (Drug)
结局指标
主要结局
Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment
时间窗: Baseline and Week 12
Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (\>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment.
Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment
时间窗: Baseline and Week 12
Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment.
次要结局
- Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12(Baseline and Week 12)
- Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment(Baseline and Week 12)
- Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12(Baseline and Week 12)
- Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12(Baseline and Week 12)
- Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12(Baseline and Week 12)
- Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12(Baseline and Week 12)
- Change From Baseline in 24-hour Blood Pressure Variability at Week 12(Baseline and Week 12)
- Heart Rate Response Rate(Week 12)
- Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12(Baseline and Week 12)
- Blood Pressure Response Rate(Week 12)