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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
DC Field | Value | Language |
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dc.contributor.author | Kang, Min-gu | - |
dc.contributor.author | Kim, Kwang-il | - |
dc.contributor.author | Ihm, Sang Hyun | - |
dc.contributor.author | Rhee, Moo-Yong | - |
dc.contributor.author | Sohn, Il Suk | - |
dc.contributor.author | Lee, Hae-Young | - |
dc.contributor.author | Park, Sungha | - |
dc.contributor.author | Jeon, Eun-Seok | - |
dc.contributor.author | Song, Jong-Min | - |
dc.contributor.author | Pyun, Wook Bum | - |
dc.contributor.author | Sung, Ki-Chul | - |
dc.contributor.author | Kim, Moo Hyun | - |
dc.contributor.author | Kim, Sang-Hyun | - |
dc.contributor.author | Kim, Seok-Yeon | - |
dc.contributor.author | Kim, Shin-Jae | - |
dc.contributor.author | Kim, Eung Ju | - |
dc.contributor.author | Shin, Jinho | - |
dc.contributor.author | Lee, Sung Yun | - |
dc.contributor.author | Chun, Kook-Jin | - |
dc.contributor.author | Jeong, Jin-Ok | - |
dc.contributor.author | Chae, Shung Chull | - |
dc.contributor.author | Yoo, Ki Dong | - |
dc.contributor.author | Choi, Young Jin | - |
dc.contributor.author | Park, Yong Hwan | - |
dc.contributor.author | Kim, Cheol-Ho | - |
dc.date.accessioned | 2019-07-09T08:07:55Z | - |
dc.date.available | 2019-07-09T17:12:55Z | - |
dc.date.issued | 2019-07-01 | - |
dc.identifier.citation | Trials. 2019 Jul 01;20(1):389 | ko_KR |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://hdl.handle.net/10371/156817 | - |
dc.description.abstract | Background
Hypertension 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. Methods This 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. Discussion Research 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 registration ClinicalTrials.gov Identifier: NCT03246555, registered on July 25, 2017. | ko_KR |
dc.description.sponsorship | The study is funded by Boryung Pharmaceutical Co., Ltd. The company was involved in all stages of the study conduct and design. Boryung also took responsibility for all costs associated with the development and publishing of the manuscript. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central | ko_KR |
dc.subject | Fimasartan | ko_KR |
dc.subject | Perindopril | ko_KR |
dc.subject | Hypertension | ko_KR |
dc.subject | Essential hypertension | ko_KR |
dc.subject | Treatment | ko_KR |
dc.subject | Elderly | ko_KR |
dc.subject | Frail elderly | ko_KR |
dc.title | 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 | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 강민구 | - |
dc.contributor.AlternativeAuthor | 김광일 | - |
dc.contributor.AlternativeAuthor | 임상현 | - |
dc.contributor.AlternativeAuthor | 이무용 | - |
dc.contributor.AlternativeAuthor | 손일석 | - |
dc.contributor.AlternativeAuthor | 이해영 | - |
dc.contributor.AlternativeAuthor | 박승하 | - |
dc.contributor.AlternativeAuthor | 전은석 | - |
dc.contributor.AlternativeAuthor | 송종민 | - |
dc.contributor.AlternativeAuthor | 편욱범 | - |
dc.contributor.AlternativeAuthor | 성기철 | - |
dc.contributor.AlternativeAuthor | 김무현 | - |
dc.contributor.AlternativeAuthor | 김상현 | - |
dc.contributor.AlternativeAuthor | 김석연 | - |
dc.contributor.AlternativeAuthor | 김신재 | - |
dc.contributor.AlternativeAuthor | 김응주 | - |
dc.contributor.AlternativeAuthor | 신진호 | - |
dc.contributor.AlternativeAuthor | 이승윤 | - |
dc.contributor.AlternativeAuthor | 전국진 | - |
dc.contributor.AlternativeAuthor | 정진옥 | - |
dc.contributor.AlternativeAuthor | 채승철 | - |
dc.contributor.AlternativeAuthor | 유기동 | - |
dc.contributor.AlternativeAuthor | 최영진 | - |
dc.contributor.AlternativeAuthor | 박용환 | - |
dc.contributor.AlternativeAuthor | 김철호 | - |
dc.identifier.doi | 10.1186/s13063-019-3466-5 | - |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s). | - |
dc.date.updated | 2019-07-07T03:39:56Z | - |
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