drugset / Trial / NCT05377203
Low-dose Quadruple Combination Therapy in Patients With Hypertension
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study aims to compare the antihypertensive effect of initial treatment with a single capsule containing quadruple combination of half-dose of blood pressure medicines or standard dose dual combination in patients with hypertension.
Timeline
- Start
- 2022-07-13
- Primary completion
- 2023-07-04
- Completion
- 2023-07-04
Publications
- Background Joint Committee for Guideline Revision. 2018 Chinese Guidelines for Prevention and Treatment of Hypertension-A report of the Revision Committee of Chinese Guidelines for Prevention and Treatment of Hypertension. J Geriatr Cardiol. 2019 Mar;16(3):182-241. doi: 10.11909/j.issn.1671-5411.2019.03.014. No abstract available.
- Background Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
- Background Lu J, Lu Y, Wang X, Li X, Linderman GC, Wu C, Cheng X, Mu L, Zhang H, Liu J, Su M, Zhao H, Spatz ES, Spertus JA, Masoudi FA, Krumholz HM, Jiang L. Prevalence, awareness, treatment, and control of hypertension in China: data from 1.7 million adults in a population-based screening study (China PEACE Million Persons Project). Lancet. 2017 Dec 9;390(10112):2549-2558. doi: 10.1016/S0140-6736(17)32478-9. Epub 2017 Nov 5.
- Background Chow CK, Gupta R. Blood pressure control: a challenge to global health systems. Lancet. 2019 Aug 24;394(10199):613-615. doi: 10.1016/S0140-6736(19)31293-0. Epub 2019 Jul 18. No abstract available.
- Background An J, Luong T, Qian L, Wei R, Liu R, Muntner P, Brettler J, Jaffe MG, Moran AE, Reynolds K. Treatment Patterns and Blood Pressure Control With Initiation of Combination Versus Monotherapy Antihypertensive Regimens. Hypertension. 2021 Jan;77(1):103-113. doi: 10.1161/HYPERTENSIONAHA.120.15462. Epub 2020 Nov 16.
- Background Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
- Zhao X, Liu T, Yang Q, Yang G, Li X, Tang X, Li J, Liang Z, Li A, Zeng L, Wen J, Wang X, Peng L, Wang W, Cai J, Chen Y, Huang M, Li R, Fu R, Zhao L, Li X, Jiang W. Initial treatment with a single capsule containing half-dose quadruple therapy vs standard-dose dual therapy in hypertensive patients (QUADUAL): a randomized, blinded, crossover trial. BMC Med. 2025 Jan 29;23(1):56. doi: 10.1186/s12916-025-03892-8.
- Zhao X, Li X, Liu T, Yang G, Chen Y, Huang M, Zhao L, Li X, Jiang W. Initial treatment with a single capsule containing half-dose quadruple therapy versus standard-dose dual therapy in hypertensive patients (QUADUAL): statistical analysis plan for a randomized, blinded, crossover trial. Trials. 2024 Jan 13;25(1):45. doi: 10.1186/s13063-023-07803-1.
- Zhao X, Chen Y, Yang G, Li X, Tang X, Yang Q, Peng L, Li J, Liang Z, Li A, Wang W, Huang M, Liu T, Li X, Jiang W. Initial treatment with a single capsule containing half-dose quadruple therapy vs standard-dose dual therapy in hypertensive patients (QUADUAL): Study protocol for a randomized, blinded, crossover trial. Am Heart J. 2023 Oct;264:10-19. doi: 10.1016/j.ahj.2023.05.019. Epub 2023 Jun 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 2.5 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 5 mg | Oral |
| Subject | Indapamide | Small molecule | 1.25 mg | Oral |
| Subject | Irbesartan | Small molecule | 75 mg | Oral |
| Subject | Irbesartan | Small molecule | 150 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 23.75 mg | Oral |