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.

ABSTRACT: This study aimed to assess the efficacy and safety of a combination therapy of Allisartan Isoproxil 240 mg and Amlodipine 5 mg (ALI/AML) compared to AML 5 mg monotherapy in patients with mild-to-moderate essential hypertension. In this phase III, multicenter, double-blind, parallel-group, randomized controlled trial, patients aged 18-70 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, following a 4-week treatment with AML 5 mg, were randomized 1:1 to receive either ALI/AML or AML once daily for 12 weeks. This 12-week double-blind period was followed by an open-label extension of ALI/AML treatment through week 52. A total of 300 patients were enrolled, with 149 and 151 patients rando

SUBMITTER: Chi H 

PROVIDER: S-EPMC11771783 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature