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

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

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Azilsartan Medoxomil Potassium Tablet; Drug: Nifedipine Sustained -release Tablets; Drug: Levoamlodipine Maleate Table

• Study Type: Observational
• Enrollment (Estimated): 1215

Contacts and Locations

• Study Contact: Name: Jun Bo Ge, academician; Phone Number: +86 13901977506; Email: ge.junbo@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Junbo Ge
      • Contact: Junbo Ge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

town hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the patient's blood pressure reached the target rate	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.	6 months

Collaborators and Investigators

• Sponsor: Hasten Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: essential hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Tocolytic Agents; Azilsartan medoxomil; Nifedipine
• Other Study ID Numbers: Ph4-HST-EDA-C-NIS-22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No