To Assess Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil

Phase 3 Completed 499 enrolled Shenzhen Salubris Pharmaceuticals Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Amlodipine besylate（5 mg) or Allisartan Isoproxil (240 mg).

Timeline

Start: 2021-04-29
Primary completion: 2022-08-16
Completion: 2023-02-24

Outcome

Met primary endpoint

paper msSBP (the primary endpoint) was significantly greater in the ALI/AML group compared to the AML group (-15.7 vs. -10.2 mmHg, p = 0.0019). PMID 39821945 ↗

Publications

Chi H, Zhang X, Ma S, Pan G, Lian X, Chen Y, Pei H, Liu Z, Lin X. Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled by Amlodipine: A Phase III, Multicenter, Double-Blind, Parallel-Group, Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14955. doi: 10.1111/jch.14955.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Allisartan Isoproxil	Unknown	240 mg	—
Subject	Allisartan Isoproxil/Amlodipine	Unknown	—	—
Comparator	Amlodipine	Other / unclassified	5 mg	—