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

Hasten Biopharmaceutical

Status: Enrolling

Conditions: Essential Hypertension

Treatments: Drug: Azilsartan Medoxomil Potassium Tablet; Drug: Levoamlodipine Maleate Table; Drug: Nifedipine Sustained -release Tablets

Study type: Observational

Funder types: Industry

Identifiers

NCT05947448

Ph4-HST-EDA-C-NIS-22-01

Details and patient eligibility

About

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

Enrollment: 1,215 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,215 participants in 3 patient groups

AZL-M single drug group

Description:

Azilsartan Medoxomil Potassium Tablet，80mg，tablet，QD，six months

Treatment:

Drug: Azilsartan Medoxomil Potassium Tablet

CCB single drug group

Description:

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.

Treatment:

Drug: Levoamlodipine Maleate Table

Drug: Nifedipine Sustained -release Tablets

AZL-M + CCB drug group（Combined medication）

Description:

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.

Treatment:

Drug: Levoamlodipine Maleate Table

Drug: Nifedipine Sustained -release Tablets

Drug: Azilsartan Medoxomil Potassium Tablet