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Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial.

Title: Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial.
Authors: Ahn HS; Division of Cardiology, Department of Internal Medicine, College of Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.; Ahn JC; Department of Cardiology, Korea University Ansan Hospital, Ansan, Republic of Korea.; Cho JM; Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University, Seoul, Republic of Korea.; Lim KH; Division of Cardiology, Dong-A University Hospital, Busan, Republic of Korea.; Han SH; Division of Cardiology, Gachon University Gil Hospital, Incheon, Republic of Korea.; Cho YK; Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.; Kim KH; Department of Cardiovascular Medicine, Chonnam National University Medical School/Hospital, Gwangju, Republic of Korea.; Hong SJ; Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.; Lee CJ; Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.; Na JO; Cardiovascular Center, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.; Sung KC; Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.; Choi K; Department of Cardiology, H-Plus Yangji Hospital, Seoul, Republic of Korea.; Kim SY; Department of Cardiology, Seoul Medical Center, Seoul, Republic of Korea.; Kim DH; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.; Lee HC; Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.; Ihm SH; Division of Cardiology, Department of Internal Medicine, Bucheon St Mary's Hospital and the Catholic Research Institute for Intractable Cardiovascular Disease, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.; Youn JC; Division of Cardiology, Department of Internal Medicine, College of Medicine, Catholic Research Institute For Intractable Cardiovascular Disease, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.; Choi JY; Division of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.; Kim SH; Department of Internal Medicine and Cardiovascular Center, Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.; Kim KI; Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.; Sung JH; Division of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.; Pyun WB; Division of Cardiology, Department of Internal Medicine, Ewha Womans University Medical Center, Seoul, Republic of Korea.; Kim WS; Cardiovascular Center, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.; Cho JS; Division of Cardiology, College of Medicine, Daejeon St. Mary's Hospital, The Catholic University of Korea, Daejeon, Republic of Korea.; Lee Y; Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea.; Her SH; Department of Cardiology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.; Cho EJ; Division of Cardiology, Department of Internal Medicine, College of Medicine, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.; Lee EM; Division of Cardiology, Department of Internal Medicine, Wonkwang University Sanbon Hospital, Gunpo, Republic of Korea.; Lee HY; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.; Yoon YW; Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.; Lee JH; Department of Cardiology, Kyungpook National University Hospital, Daegu, Republic of Korea.; Kim W; Division of Cardiovascular, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea.; Rhee SJ; Division of Cardiology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Republic of Korea.; Shin J; Division of Cardiology, Department of Internal Medicine, Hanyang University Seoul Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea.
Source: Journal of clinical hypertension (Greenwich, Conn.) [J Clin Hypertens (Greenwich)] 2026 May; Vol. 28 (5), pp. e70279.
Publication Type: Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Multicenter Study
Language: English
Journal Info: Publisher: Wiley Periodicals Inc Country of Publication: United States NLM ID: 100888554 Publication Model: Print Cited Medium: Internet ISSN: 1751-7176 (Electronic) Linking ISSN: 15246175 NLM ISO Abbreviation: J Clin Hypertens (Greenwich) Subsets: MEDLINE
Imprint Name(s): Publication: : [Hoboken, NJ] : Wiley Periodicals Inc.; Original Publication: Greenwich, CT : Le Jacq Communication, Inc., c1999-
MeSH Terms: Amlodipine*/administration & dosage ; Amlodipine*/adverse effects ; Amlodipine*/therapeutic use ; Telmisartan*/administration & dosage ; Telmisartan*/adverse effects ; Essential Hypertension*/drug therapy ; Essential Hypertension*/physiopathology ; Antihypertensive Agents*/administration & dosage ; Antihypertensive Agents*/adverse effects ; Antihypertensive Agents*/therapeutic use ; Hypertension*/drug therapy; Blood Pressure/drug effects ; Humans ; Middle Aged ; Male ; Female ; Double-Blind Method ; Treatment Outcome ; Aged ; Drug Combinations ; Adult ; Dose-Response Relationship, Drug
Abstract: Low-dose single-pill combinations (SPCs) are gaining recognition as an efficient therapeutic strategy for mild hypertension. However, evidence from randomized controlled trials regarding the efficacy and safety of half-dose telmisartan/amlodipine SPCs remains limited. In this randomized, double-blind, active-controlled phase III trial, patients with essential hypertension [mean sitting systolic blood pressure (MSSBP) ≥ 140 and < 180 mmHg] were allocated to four treatment arms to receive either telmisartan/amlodipine 20/2.5 mg SPC (TEL/AML 20/2.5), or monotherapy with telmisartan 20 mg (TEL 20), amlodipine 2.5 mg (AML 2.5), or telmisartan 40 mg (TEL 40) once daily for 8 weeks. The primary endpoint was the change in MSSBP from baseline to week 8. A gatekeeping approach was used to test the superiority of TEL/AML 20/2.5 over TEL 20 and AML 2.5, followed by non-inferiority versus TEL 40. At week 8, TEL/AML 20/2.5 showed significantly greater MSSBP reductions compared with TEL 20 [least squares mean (LSM) differences: -5.79 mmHg; p = 0.0003] and AML 2.5 (-8.57 mmHg; p < 0.0001). Non-inferiority to TEL 40 was established, with an LSM difference of -3.88 mmHg (95% Confidence Interval: -6.67 to -1.09), which met the pre-specified 3 mmHg margin. The overall incidence of adverse events was 8.05%, with no statistically significant differences between groups. Overall, TEL/AML 20/2.5 SPC provided superior BP-lowering efficacy compared with TEL 20 and AML 2.5 monotherapies and was non-inferior to TEL 40. With a comparable safety profile across treatment groups, these findings suggest that TEL/AML 20/2.5 is a practical and effective option for hypertension management. Trial Registration: ClinicalTrials.gov, NCT06052748.; (© 2026 The Author(s). The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)
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Grant Information: Yuhan Corporation
Contributed Indexing: Keywords: hypertension; low‐dose therapy; randomized controlled trial; single‐pill combination; telmisartan/amlodipine
Molecular Sequence: ClinicalTrials.gov NCT06052748
Substance Nomenclature: 1J444QC288 (Amlodipine); U5SYW473RQ (Telmisartan); 0 (Antihypertensive Agents); 0 (Drug Combinations); 0 (telmisartan amlodipine combination)
Entry Date(s): Date Created: 20260514 Date Completed: 20260514 Latest Revision: 20260516
Update Code: 20260516
PubMed Central ID: PMC13172608
DOI: 10.1111/jch.70279
PMID: 42130156
Database: MEDLINE

Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Multicenter Study