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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

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Authors
Kang, Min-gu; Kim, Kwang-il; Ihm, Sang Hyun; Rhee, Moo-Yong; Sohn, Il Suk; Lee, Hae-Young; Park, Sungha; Jeon, Eun-Seok; Song, Jong-Min; Pyun, Wook Bum; Sung, Ki-Chul; Kim, Moo Hyun; Kim, Sang-Hyun; Kim, Seok-Yeon; Kim, Shin-Jae; Kim, Eung Ju; Shin, Jinho; Lee, Sung Yun; Chun, Kook-Jin; Jeong, Jin-Ok; Chae, Shung Chull; Yoo, Ki Dong; Choi, Young Jin; Park, Yong Hwan; Kim, Cheol-Ho
Issue Date
2019-07-01
Publisher
BioMed Central
Citation
Trials. 2019 Jul 01;20(1):389
Keywords
FimasartanPerindoprilHypertensionEssential hypertensionTreatmentElderlyFrail elderly
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.
ISSN
1745-6215
Language
English
URI
http://hdl.handle.net/10371/156817
DOI
https://doi.org/10.1186/s13063-019-3466-5
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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