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Clinical Trial
. 2025 Jul;39(7):500-508.
doi: 10.1038/s41371-025-01035-3. Epub 2025 Jun 17.

Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients with Essential Hypertension: A Phase III, Multicenter, Double-Blind, Parallel-Group, Randomised study

Hongjie Chi #  1 , Xin Zhang #  2 , Shumei Ma  3 , Gang Pan  4 , Xiaojuan Lian  5 , Yuanyuan Chen  5 , Yan Chen  5 , Hao Tang  5 , Zichen Liu  5 , Peng Mi  5 , Xiangmin Lin  6
Affiliations
Clinical Trial

Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients with Essential Hypertension: A Phase III, Multicenter, Double-Blind, Parallel-Group, Randomised study

Hongjie Chi et al. J Hum Hypertens. 2025 Jul.

Abstract

This multicenter, double-blind, parallel-group, randomised controlled phase III study evaluated the efficacy and safety of the Allisartan Isoproxil 240 mg /Amlodipine 5 mg (ALI/AML) combination compared with ALI 240 mg monotherapy in patients with mild-to-moderate essential hypertension. Patients aged 18 to 70 years with mean sitting systolic blood pressure (msSBP) between 140 and <180 mmHg and mean sitting diastolic blood pressure (msDBP) between 90 and <110 mmHg were randomised 1:1 to receive ALI/AML or ALI once-daily for 12 weeks after a 4-week treatment with ALI, followed by an open-label extension period with ALI/AML up to week 52. A total of 199 patients were randomised (ALI/AML: n = 99, ALI: n = 100) with 169 completing the study. Baseline characteristics were comparable between groups. After 12 weeks of randomisation, the reduction in msSBP (primary endpoint) was significantly greater in the ALI/AML group vs the ALI group (-18.3 vs. -9.3 mmHg, p < 0.001). Reductions in msDBP (-6.0 vs. -1.9 mmHg, p < 0.001) and 24-hour mean ambulatory systolic/diastolic blood pressure (-19.9/-10.1 vs. -6.9/-4.2 mmHg) were more pronounced in the ALI/AML group. Additionally, a greater proportion of patients achieved the BP response and target office BP in the ALI/AML group compared to the ALI group (53.6% vs. 25.5%, p < 0.001; 40.2% vs. 20.4%, p=0.0026). AML/ALI combination was generally safe and well tolerated, with sustained efficacy up to 52 weeks. The study concluded that ALI/AML offers a convenient, single-pill option for effective BP reduction in hypertensive patients.

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Conflict of interest statement

Competing interests: Xiaojuan Lian, Yuanyuan Chen, Yan Chen, Hao Tang, Zichen Liu, and Peng Mi are employees of Shenzhen Salubris Pharmaceuticals Co., LTD. Other authors declare no conflict of interest. Ethics Approval and Consent to Participate: This study was approved by the Ethics Committee of the Beijing Chaoyang Hospital affiliated with the Capital Medical University(No. 2020-Medicine-89-3); prior to study enrollment and any of the study procedures, written informed consent was obtained from all subjects. Consent for Publication: All authors critically reviewed and approved the publication of the final paper.

Figures

Fig. 1
Fig. 1
Patient disposition.
Fig. 2
Fig. 2
Comparison of change from baseline to Week 12 in msSBP and msDBP between ALI/AML (240/5 mg) and ALI (240 mg) groups(MMRM). LSM indicates least square mean.
Fig. 3
Fig. 3. Proportion of responders and target BP rates in the double-blind period (Logistic Regression).
a Proportion of responders (msSBP/msDBP<140/90 mmHg, or a reduction in msSBP >20 mmHg and/or mean msDBP >10 mmHg). b Target BP rates (msSBP/msDBP<140/90 mmHg).
Fig. 4
Fig. 4
Changes in msSBP from baseline to Week 12 in different subgroups between ALI/AML (240/5 mg) and ALI (240 mg) groups. LSM indicates least square mean(MMRM).
Fig. 5
Fig. 5
LSM change from baseline to Week 12 in ambulatory blood pressure between ALI/AML (240/5 mg) and ALI (240 mg) groups (ANCOVA). LSM indicates least square mean(MMRM).
Fig. 6
Fig. 6. Postdosing hourly mean ambulatory SBP and DBP at Week 12 with Allisartan Isoproxil/Amlodipine vs. Allisartan Isoproxil groups.
a Mean ambulatory SBP (n = 8). b Mean ambulatory DBP (n = 9).
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