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 | Unknown

• 1 other identifier: Ph4-HST-EDA-C-NIS-22-01
• Study Type: observational
• Target: 1,215
• Locations: 1 country
• Sites: 1

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

Keywords

essential hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

AZL-M single drug group

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

Drug: Azilsartan Medoxomil Potassium Tablet

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; Drug: Levoamlodipine Maleate Table

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; Drug: Nifedipine Sustained -release Tablets; Drug: Levoamlodipine Maleate Table

Interventions

Azilsartan Medoxomil Potassium Tablet DRUG

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

AZL-M + CCB drug group（Combined medication）; AZL-M single drug group

Nifedipine Sustained -release Tablets DRUG

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

AZL-M + CCB drug group（Combined medication）; CCB single drug group

Levoamlodipine Maleate Table DRUG

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

AZL-M + CCB drug group（Combined medication）; CCB single drug group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

town hospital

You may qualify if:

• Age ≥ 18 years old (one year old);
• Patients diagnosed with essential hypertension;
• Did not receive any antihypertensive drug treatment for at least 3 months before enrollment;
• 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.

You may not qualify if:

• Used antihypertensive drugs for indications other than hypertension within 3 months before enrollment;
• Has a history of alcoholism, drug abuse or illegal drug use;
• Pregnant, breastfeeding women, and those who plan to become pregnant in the near future;
• Life expectancy is less than one year; Participating in other clinical trials.

Sponsors & Collaborators

• Hasten Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Junbo Ge

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jun Bo Ge, academician

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: January 22, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2024

Record last verified: 2023-07

Locations

CN (1)