{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T05:09:18Z","timestamp":1764047358871,"version":"3.41.2"},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,1,17]],"date-time":"2025-01-17T00:00:00Z","timestamp":1737072000000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Clinical Hypertension"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This study aimed to assess the efficacy and safety of a combination therapy of Allisartan Isoproxil 240\u00a0mg and Amlodipine 5\u00a0mg (ALI\/AML) compared to AML 5\u00a0mg monotherapy in patients with mild\u2010to\u2010moderate essential hypertension. In this phase III, multicenter, double\u2010blind, parallel\u2010group, randomized controlled trial, patients aged 18\u201370 years with mean sitting systolic blood pressure (msSBP) between 140 and &lt;180\u00a0mmHg and mean sitting diastolic blood pressure (msDBP) between 90 and &lt;110\u00a0mmHg, following a 4\u2010week treatment with AML 5\u00a0mg, were randomized 1:1 to receive either ALI\/AML or AML once daily for 12 weeks. This 12\u2010week double\u2010blind period was followed by an open\u2010label extension of ALI\/AML treatment through week 52. A total of 300 patients were enrolled, with 149 and 151 patients randomly assigned to ALI\/AML and AML groups, respectively. Of these, 257 patients completed the study. Baseline demographics and characteristics were comparable between groups. After 12 weeks, the reduction in msSBP (the primary endpoint) was significantly greater in the ALI\/AML group compared to the AML group (\u201315.7\u00a0vs. \u201310.2\u00a0mmHg, <jats:italic>p<\/jats:italic> = 0.0019). Similarly, reductions in msDBP (\u20135.7\u00a0vs. \u20132.4\u00a0mmHg, <jats:italic>p\u00a0<\/jats:italic>&lt;\u00a00.001) and 24\u2010h mean ambulatory SBP and DBP (\u201310.4 and \u20137.7\u00a0mmHg vs. \u20135.6 and \u20133.8\u00a0mmHg) were more pronounced in the ALI\/AML group. Additionally, a higher proportion of patients achieved both a BP response and target office BP in the ALI\/AML group compared to the AML group (51.4%\u00a0vs. 37.4%, 42.5%\u00a0vs. 30.6%, both <jats:italic>p\u00a0<\/jats:italic>&lt;\u00a00.05). The ALI\/AML combination was generally well tolerated, and the antihypertensive effect was maintained for up to 52 weeks. In patients with essential hypertension inadequately controlled by AML, the ALI\/AML combination provided superior reductions in msSBP and was significantly more effective than AML monotherapy. This once\u2010daily single\u2010pill combination demonstrated promising efficacy and tolerability.<\/jats:p><jats:p><jats:bold>Trial Registration<\/jats:bold>: ClinicalTrials.gov identifier: NCT06465264<\/jats:p>","DOI":"10.1111\/jch.14955","type":"journal-article","created":{"date-parts":[[2025,1,17]],"date-time":"2025-01-17T15:22:13Z","timestamp":1737127333000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and Safety of Allisartan Isoproxil\/Amlodipine in Patients With Essential Hypertension Uncontrolled by Amlodipine: A Phase III, Multicenter, Double\u2010Blind, Parallel\u2010Group, Randomized Controlled Trial"],"prefix":"10.1111","volume":"27","author":[{"given":"Hongjie","family":"Chi","sequence":"first","affiliation":[{"name":"Department of Cardiology, Beijing Chaoyang Hospital Capital Medical University Beijing China"},{"name":"Heart Center and Beijing Key Laboratory of Hypertension Beijing Chaoyang Hospital Capital Medical University Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Cardiology The First Affiliated Hospital of Baotou Medical College Baotou City Inner Mongolia China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shumei","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Cardiology Shengjing Hospital of China Medical University Shenyang Liaoning Province China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gang","family":"Pan","sequence":"additional","affiliation":[{"name":"Department of Cardiology Yueyang Central Hospital Yueyang City Hunan Province China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaojuan","family":"Lian","sequence":"additional","affiliation":[{"name":"Department of Medical Development Shenzhen Salubris Pharmaceuticals Co., LTD Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Medical Development Shenzhen Salubris Pharmaceuticals Co., LTD Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haotian","family":"Pei","sequence":"additional","affiliation":[{"name":"Department of Medical Development Shenzhen Salubris Pharmaceuticals Co., LTD Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zichen","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Medical Development Shenzhen Salubris Pharmaceuticals Co., LTD Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0806-0508","authenticated-orcid":false,"given":"Xiangmin","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Beijing Chaoyang Hospital Capital Medical University Beijing China"},{"name":"Heart Center and Beijing Key Laboratory of Hypertension Beijing Chaoyang Hospital Capital Medical University Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,17]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41581-019-0244-2"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2018.14"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.032380"},{"issue":"3","key":"e_1_2_12_5_1","first-page":"182","article-title":"2018 Chinese Guidelines for Prevention and Treatment of Hypertension\u2014A Report of the Revision Committee of Chinese Guidelines for Prevention and Treatment of Hypertension","volume":"16","author":"Joint Committee for Guideline Revision","year":"2019","journal-title":"Journal of Geriatric Cardiology"},{"issue":"1","key":"e_1_2_12_6_1","first-page":"1","article-title":"China Cardiovascular Diseases Report 2018: An Updated Summary","volume":"17","author":"Ma L. 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