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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 | Clinical Trials | Clareo Health

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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

NCT05947448•Hasten Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Junbo Ge

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 22, 2024

Primary Completion Date

June 30, 2025

Completion Date

December 31, 2025

Last Updated

April 1, 2024

Enrollment

1,215

ESTIMATED participants

Conditions

Essential Hypertension

Interventions

Azilsartan Medoxomil Potassium Tablet

DRUG

Nifedipine Sustained -release Tablets

DRUG

Levoamlodipine Maleate Table

DRUG

Contacts

Jun Bo Ge, academician

CONTACT

+86 13901977506 ge.junbo@zs-hospital.sh.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

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