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

NCT ID: NCT05947448

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2025-12-31

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

Conditions

Essential Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AZL-M single drug group

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

Azilsartan Medoxomil Potassium Tablet

Intervention Type: DRUG

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.

Nifedipine Sustained -release Tablets

Intervention Type: DRUG

Nifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months；

Levoamlodipine Maleate Table

Intervention Type: DRUG

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.

Azilsartan Medoxomil Potassium Tablet

Intervention Type: DRUG

Azilsartan Medoxomil Potassium Tablet，80mg，qd，lasts six month

Nifedipine Sustained -release Tablets

Intervention Type: DRUG

Nifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months；

Levoamlodipine Maleate Table

Intervention Type: DRUG

Levoamlodipine Maleate Table，qd，The maximum clinical dose，lasts six months；

Interventions

Azilsartan Medoxomil Potassium Tablet

Azilsartan Medoxomil Potassium Tablet，80mg，qd，lasts six month

Intervention Type: DRUG

Nifedipine Sustained -release Tablets

Nifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months；

Intervention Type: DRUG

Levoamlodipine Maleate Table

Levoamlodipine Maleate Table，qd，The maximum clinical dose，lasts six months；

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasten Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Junbo Ge

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Bo Ge, academician

Role: CONTACT

ge.junbo@zs-hospital.sh.cn

+86 13901977506

Facility Contacts

Junbo Ge

Role: primary

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id