Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,215
- 试验地点
- 1
- 主要终点
- the patient's blood pressure reached the target rate
研究概览
简要总结
This is a national multicenter, prospective, observational study. It is planned to enroll 1215 patients with newly diagnosed essential hypertension in 80 centers, and divide them into 3 groups according to different treatment plans given by doctors: AZL-M monotherapy group, CCB monotherapy group (amlodipine besylate tablets or nifedipine controlled-release tablets) and AZL-M+CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) combined treatment group. Subjects were visited 4 times at baseline, 1 month, 3 months, and 6 months, and the following key indicators of subjects were measured according to the doctor's decision, and the measurement results were collected
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old (one year old);
- •Patients diagnosed with essential hypertension;
- •Did not receive any antihypertensive drug treatment for at least 3 months before enrollment;
- •Eligible to use 80 mg once-daily AZL-M at baseline or CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) or CCB (besylate Amlodipine tablets or nifedipine controlled-release tablets) + AZL-M 80 mg once-daily combination therapy; Volunteer to participate in this study, understand and sign the written informed consent.
排除标准
- •Used antihypertensive drugs for indications other than hypertension within 3 months before enrollment;
- •Has a history of alcoholism, drug abuse or illegal drug use;
- •Pregnant, breastfeeding women, and those who plan to become pregnant in the near future;
- •Life expectancy is less than one year; Participating in other clinical trials.
研究组 & 干预措施
AZL-M single drug group
Azilsartan Medoxomil Potassium Tablet，80mg，tablet，QD，six months
干预措施: Azilsartan Medoxomil Potassium Tablet (Drug)
CCB single drug group
Nifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；or Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； Doctor choose a medication that is more suitable for patient treatment.
干预措施: Nifedipine Sustained -release Tablets (Drug)
CCB single drug group
Nifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；or Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； Doctor choose a medication that is more suitable for patient treatment.
干预措施: Levoamlodipine Maleate Table (Drug)
AZL-M + CCB drug group（Combined medication）
Nifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；and Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； When the patient's upper pressure exceeds 160 Millimetre of mercury, the doctor will choose combination medication .CCB drug will be chosen either Nifedipine Controller-release Tablets or Levoamlodipine Maleate Table.
干预措施: Azilsartan Medoxomil Potassium Tablet (Drug)
AZL-M + CCB drug group（Combined medication）
Nifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；and Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； When the patient's upper pressure exceeds 160 Millimetre of mercury, the doctor will choose combination medication .CCB drug will be chosen either Nifedipine Controller-release Tablets or Levoamlodipine Maleate Table.
干预措施: Nifedipine Sustained -release Tablets (Drug)
AZL-M + CCB drug group（Combined medication）
Nifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；and Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； When the patient's upper pressure exceeds 160 Millimetre of mercury, the doctor will choose combination medication .CCB drug will be chosen either Nifedipine Controller-release Tablets or Levoamlodipine Maleate Table.
干预措施: Levoamlodipine Maleate Table (Drug)
结局指标
主要结局
the patient's blood pressure reached the target rate
时间窗: 6 months
Ø Compliance rate of systolic blood pressure (SBP) in the clinic: the proportion of subjects whose blood pressure dropped to sitting systolic blood pressure (sitSBP) \<140 mmHg or compared with the baseline value of sitSBP ≥ 20mmHg; Ø Compliance rate of diastolic blood pressure (DBP) in the clinic: the proportion of subjects whose blood pressure dropped to sitting diastolic blood pressure (sitDBP) \<90 mmHg or compared with the baseline value of sitDBP decreased by ≥10mmHg; Ø Achievement rate of both SBP and DBP in the clinic: the proportion of subjects who meet the SBP and DBP standards in the above clinics at the same time.
次要结局
未报告次要终点