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

Essential Hypertension Clinical Trial

Official title:

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 Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947448
• Other study ID #: Ph4-HST-EDA-C-NIS-22-01
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Hasten Biopharmaceutical Co., Ltd.
• Contact: Jun Bo Ge, academician
• Phone: +86 13901977506
• Email: ge.junbo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1215
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Azilsartan Medoxomil Potassium Tablet
Azilsartan Medoxomil Potassium Tablet,80mg,qd,lasts six month
• Nifedipine Sustained -release Tablets
Nifedipine Sustained -release Tablets,qd,The maximum clinical dose,lasts six months;
• Levoamlodipine Maleate Table
Levoamlodipine Maleate Table,qd,The maximum clinical dose,lasts six months;

Locations

Country	Name	City	State
China	Junbo Ge	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hasten Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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