Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Diastolic blood pressure
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of Arotinolol Hydrochloride and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in patients with essential hypertension. To provide evidence for hypertension treatment.
A group: Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. B group: Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
详细描述
Compare the efficacy and safety of Arotinolol Hydrochloride and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in patients with essential hypertension.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with systolic blood pressure between 140-179mmHg and/or diastolic blood pressure between 90-109mmHg.
- •Aged between 18-65 years old.
- •Signed informed consent.
排除标准
- •Secondary hypertension
- •Patients who taking amiodarone over 200mg/day to control arrhythmia
- •Patients who taking class I antiarrhythmic drugs
- •Resting heart rate less than 60bpm
- •Serious liver and kidney disease: aspartate aminotransferase (AST) or alanine aminotransferase) (ALT)>2.5 times upper limit of normal; serum creatinine>3mg/dl (265umol/L)
- •Severe heart failure: New York Heart Association (NYHA) functional class 2, 3, 4
- •Myocardial infarction or stroke in the last three months. Unstable angina pectoris in the last month.
- •Patients with asthma or chronic obstructive pulmonary disease.
- •Pregnancy and breast-feeding
- •Patients allergy to investigational drugs or have contraindication to investigational drugs.
- •Others unsuitable to participate in the study judged by investigator.
研究组 & 干预措施
arotinolol
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks
干预措施: Arotinolol Hydrochloride (Drug)
Metoprolol
Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
干预措施: Metoprolol succinate sustained-release tablet (Drug)
结局指标
主要结局
Diastolic blood pressure
时间窗: 12 weeks
Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment
次要结局
- Morning surge(12 weeks)
- Morning blood pressure (BP) by office BP measure(12 weeks)
- Pulse wave velocity (PWV)(12 weeks)
- The increase rate of morning blood pressure(12 weeks)
- Heart rate by office BP measure(12 weeks)
- Albumin-to-creatinine ratio (ACR)(12 weeks)
- Systolic blood pressure(12 weeks)
- Ankle-brachial index (ABI)(12 weeks)
- Glomerular filtration rate (GFR)(12 weeks)