NCT05947448

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,215 (estimated)
• Sponsor: Hasten Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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；

Timeline

• Start date: 2024-01-22
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-07-17
• Last updated: 2024-04-01

Locations

1 site across 1 country: China