A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Nighttime systolic blood pressure reduction
研究概览
简要总结
This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives. Half of participants will receive Nifedipine GITS, half of half will take medicine in the morning or at night. While the other half participants will take amlodipine besylate, whom will also be assigned taking medicine in the morning or at night. Ambulatory blood pressure monitoring and arterial stiffness examination will be performed before and after pharmaceutical intervention.
详细描述
Written informed consent will obtained from all the participants. All the adverse reaction or adverse event, related or unrelated to the study drug, will be recorded in detail, including the occurrence time, symptoms and vital signs, degree, duration, laboratory test indexes, treatment methods and results, process, follow-up time, etc.
If serious adverse event occurs, study drugs should be stopped and necessary remedy should be delivered immediately. At the same time, the investigator must report it to the local drug supervision, medical ethics committee and China Food and Drug 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate (Office blood pressure : 140 mmHg =< systolic blood pressure (SBP) <180 mmHg and / or 90 mmHg =< diastolic blood pressure (DBP) <110 mmHg) , non-dipper (ambulatory blood pressure monitoring (ABPM): night-time mean SBP / day-time mean SBP >=0.9 and night-time mean SBP >=120 mmHg) hypertensive subjects, who is drug treatment-naive or previously treated but discontinued for 2 weeks or more
- •The subject is voluntary to participate in the study and has signed the informed consent form
排除标准
- •Known allergy to any component of Nifedipine and Amlodipine
- •Office SBP >=180 mmHg and / or DBP >=110 mmHg in the screening period
- •The patient who is taking calcium antagonists (monotherapy or combination with other drugs)
- •Evidences of secondary hypertension
- •History of cerebrovascular events, cardiac failure, serious coronary artery disease within 12 months
- •Type 1 diabetes mellitus (DM)
- •Severe liver diseases or renal insufficiency
- •The pregnant woman, the woman who may be pregnant or plan to be pregnant, or the lactating woman
- •The subject who needs to work at night (on night shift)
- •Other reasons that the subject can not participate in the study
研究组 & 干预措施
Nifedipine GITS
Nifedipine GITS 30~60mg/day
干预措施: Nifedipine GITS (Drug)
Amlodipine besylate
Amlodipine besylate 5~10mg/day
干预措施: Amlodipine besylate (Drug)
结局指标
主要结局
Nighttime systolic blood pressure reduction
时间窗: 8 weeks
Compare the effects of two active drugs on nighttime systolic blood pressure reduction
次要结局
- The proportion of recovery of dipper rhythm of blood pressure(8 weeks)
- Change of pulse wave velocity(8 weeks)
研究者
Jing Liu
Chief Physician
Peking University People's Hospital