Essential Hypertension
Conditions
Keywords
essential hypertension
Brief summary
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
Interventions
DRUGAzilsartan Medoxomil Potassium Tablet
Azilsartan Medoxomil Potassium Tablet，80mg，qd，lasts six month
DRUGNifedipine Sustained -release Tablets
Nifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months；
DRUGLevoamlodipine Maleate Table
Levoamlodipine Maleate Table，qd，The maximum clinical dose，lasts six months；
Sponsors
Hasten Biopharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old (one year old); 2. Patients diagnosed with essential hypertension; 3. Did not receive any antihypertensive drug treatment for at least 3 months before enrollment; 4. 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.
Exclusion criteria
1. Used antihypertensive drugs for indications other than hypertension within 3 months before enrollment; 2. Has a history of alcoholism, drug abuse or illegal drug use; 3. Pregnant, breastfeeding women, and those who plan to become pregnant in the near future; 4. Life expectancy is less than one year; Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the patient's blood pressure reached the target rate | 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. |
Countries
China
Contacts
Primary ContactJun Bo Ge, academician
Outcome results
None listed