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
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AZL-M single drug group Azilsartan Medoxomil Potassium Tablet，80mg，tablet，QD，six months |
Drug: Azilsartan Medoxomil Potassium Tablet
Azilsartan Medoxomil Potassium Tablet，80mg，qd，lasts six month
|
| 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. |
Drug: Nifedipine Sustained -release Tablets
Nifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months；
Drug: Levoamlodipine Maleate Table
Levoamlodipine Maleate Table，qd，The maximum clinical dose，lasts six months；
|
| 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. |
Drug: Azilsartan Medoxomil Potassium Tablet
Azilsartan Medoxomil Potassium Tablet，80mg，qd，lasts six month
Drug: Nifedipine Sustained -release Tablets
Nifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months；
Drug: Levoamlodipine Maleate Table
Levoamlodipine Maleate Table，qd，The maximum clinical dose，lasts six months；
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hasten Biopharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Ph4-HST-EDA-C-NIS-22-01