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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

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Last updated:23rd Jul 2023
Status: NOT YET RECRUITING
Identifier: 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


ClinicalTrials.gov ID: NCT05947448

Sponsor: Hasten Biopharmaceutical Co., Ltd.
Information provided by: Hasten Biopharmaceutical Co., Ltd. (Responsible Party)
Last Update Posted: 2023-07-24

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

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

Intervention / Treatment:
- Drug: Azilsartan Medoxomil Potassium Tablet
- Drug: Nifedipine Sustained -release Tablets
- Drug: Levoamlodipine Maleate Table

Category Value
Study Start (Estimated) 2023-09-25
Primary Completion (Estimated) 2025-12-25
Study Completion (Estimated) 2026-05-25
Enrollment (Estimated) 1215
Study Type Observational 
Other Study ID Numbers

Ph4-HST-EDA-C-NIS-22-01

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