Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial

Trials

  ^{1    2    3    4    5    6    7    8    9    1,10    1,11    1,12    1,13    1,14    1,15    1,16    1,16    1,17    1,18    1,19    2,20    2,21    2,22    2,23    2,24} 

[1] 0000 0001 0302 820X, grid.412484.f, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, Republic of Korea;0000 0001 0356 9399, grid.14005.30, Department of Internal Medicine, Chonnam National University Bitgoeul Hospital, 61748, Gwang-ju, Republic of Korea;0000 0001 0661 1556, grid.258803.4, Department of Internal Medicine, School of Medicine, Kyungpook National University, 130, Dongdeok-ro, Jung-gu, Daegu, Republic of Korea;0000 0001 2171 7754, grid.255649.9, Department of Internal Medicine, Ewha Womans University Seoul Hospital, 260, Gonghangdae-ro, Gangseo-gu, Seoul, Republic of Korea;0000 0001 2181 989X, grid.264381.a, Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29, Saemunan-ro, Jongno-gu, Seoul, Republic of Korea;0000 0004 0371 8173, grid.411633.2, Department of Internal Medicine, Inje University Ilsan Paik Hospital, 170, Juhwa-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, Republic of Korea;0000 0004 0442 9883, grid.412591.a, Department of Internal Medicine, Pusan National University Yangsan Hospital, 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, Republic of Korea;0000 0004 0470 4224, grid.411947.e, Department of Internal Medicine, The Catholic University of Korea Bucheon ST. Mary’s Hospital, 327, Sosa-ro, Bucheon-si, Gyeonggi-do, Republic of Korea;0000 0004 0470 5905, grid.31501.36, Department of Internal Medicine, Seoul National University Borame Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, Republic of Korea;0000 0004 0474 0479, grid.411134.2, Department of Internal Medicine, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, Republic of Korea;0000 0004 0533 4667, grid.267370.7, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea;0000 0004 0636 3064, grid.415562.1, Department of Internal Medicine, Yonsei University Health System, Severance Hospital, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea;0000 0004 0642 340X, grid.415520.7, Department of Internal Medicine, Seoul Medical Center, 156, Sinnae-ro, Jungnang-gu, Seoul, Republic of Korea;0000 0004 0647 1081, grid.412048.b, Department of Internal Medicine, Dong-A University Hospital, 26, Daesingongwon-ro, Seo-gu, Busan, Republic of Korea;0000 0004 0647 2279, grid.411665.1, Department of Internal Medicine, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, Republic of Korea;0000 0001 0722 6377, grid.254230.2, Chungnam National University, 99 Daehak-ro, Yuseong-gu, 34134, Daejeon, Republic of Korea;0000 0004 0647 3378, grid.412480.b, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Gumi-ro 166, Bundang-gu, 463-707, Seongnam-si, Kyeongi-do, Republic of Korea;0000 0004 0647 539X, grid.412147.5, Department of Internal Medicine, Hanyang University Hospital, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea;0000 0004 0647 7248, grid.412830.c, Department of Internal Medicine, Ulsan University Hospital, 877, Bangeojinsunhwando-ro, Dong-gu, Ulsan, Republic of Korea;0000 0004 0647 774X, grid.416965.9, Department of Internal Medicine, The Catholic University of Korea, ST. Vincent’s Hospital, 93-1, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do, Republic of Korea;0000 0004 1792 3864, grid.470090.a, Cardiovascular Center, Dongguk University Ilsan Hospital, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea;Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, 158, Paryong-ro, Masanhoewon-gu, Changwon-si, Gyeongsangnam-do, Republic of Korea;Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan, University School of Medicine, 81 Irwon-Ro Gangnam-gu, Seoul, Republic of Korea;Department of Internal Medicine, Sejong Hospital, 28, Hohyeon-ro 489beon-gil, Bucheon-si, Gyeonggi-do, Republic of Korea;grid.496794.1, Department of Cardiology, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, Republic of Korea;

关键词: Fimasartan;    Perindopril;    Hypertension;    Essential hypertension;    Treatment;    Elderly;    Frail elderly;   

DOI  :  10.1186/s13063-019-3466-5

来源: publisher

【 摘 要 】

BackgroundHypertension is an important risk factor for cardiovascular disease, even in the elderly. Fimasartan is a new non-peptide angiotensin II receptor blocker with a selective type I receptor blocking effect. The objective of this study is to confirm the safety and the non-inferiority of the blood pressure–lowering effect of fimasartan compared with those of perindopril, which has been proven safe and effective in elderly patients with hypertension.MethodsThis is a randomized, double-blind, active-controlled, two-parallel group, optional-titration, multicenter, phase 3 study comparing the efficacy and safety of fimasartan and perindopril arginine. The study population consists of individuals 70 years old or older with essential hypertension. The primary outcome will be a change in sitting systolic blood pressure from baseline after the administration of the investigational product for 8 weeks. The secondary outcomes will be a change in sitting diastolic blood pressure from baseline and changes in sitting systolic blood pressure and diastolic blood pressure from baseline after the administration of the investigational product for 4, 16, and 24 weeks. The sample size will be 119 subjects for each group to confer enough power to test for the primary outcome.DiscussionResearch to confirm the efficacy and safety of a new medicine compared with those of previously proven anti-hypertensive drugs is beneficial to guide physicians in the selection of therapeutic agents. If it is confirmed that the new drug is not inferior to the existing drug, the drug will be considered as an option in the treatment of hypertension in elderly patients.Trial registrationClinicalTrials.gov Identifier: NCT03246555, registered on July 25, 2017.

【 授权许可】

CC BY