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
Min-gu Kang,
Kwang-il Kim,
Sang Hyun Ihm,
Moo-Yong Rhee,
Il Suk Sohn,
Hae-Young Lee,
Sungha Park,
Eun-Seok Jeon,
Jong-Min Song,
Wook Bum Pyun,
Ki-Chul Sung,
Moo Hyun Kim,
Sang-Hyun Kim,
Seok-Yeon Kim,
Shin-Jae Kim,
Eung Ju Kim,
Jinho Shin,
Sung Yun Lee,
Kook-Jin Chun,
Jin-Ok Jeong,
Shung Chull Chae,
Ki Dong Yoo,
Young Jin Choi,
Yong Hwan Park,
Cheol-Ho Kim
Affiliations
Min-gu Kang
Department of Internal Medicine, Chonnam National University Bitgoeul Hospital
Kwang-il Kim
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Sang Hyun Ihm
Department of Internal Medicine, The Catholic University of Korea Bucheon ST. Mary’s Hospital
Moo-Yong Rhee
Cardiovascular Center, Dongguk University Ilsan Hospital
Il Suk Sohn
Department of Cardiology, Kyung Hee University Hospital at Gangdong
Hae-Young Lee
Department of Internal Medicine, Seoul National University Hospital
Sungha Park
Department of Internal Medicine, Yonsei University Health System, Severance Hospital
Eun-Seok Jeon
Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan, University School of Medicine
Jong-Min Song
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine
Wook Bum Pyun
Department of Internal Medicine, Ewha Womans University Seoul Hospital
Ki-Chul Sung
Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Moo Hyun Kim
Department of Internal Medicine, Dong-A University Hospital
Sang-Hyun Kim
Department of Internal Medicine, Seoul National University Borame Medical Center
Seok-Yeon Kim
Department of Internal Medicine, Seoul Medical Center
Shin-Jae Kim
Department of Internal Medicine, Ulsan University Hospital
Eung Ju Kim
Department of Internal Medicine, Korea University Guro Hospital
Jinho Shin
Department of Internal Medicine, Hanyang University Hospital
Sung Yun Lee
Department of Internal Medicine, Inje University Ilsan Paik Hospital
Kook-Jin Chun
Department of Internal Medicine, Pusan National University Yangsan Hospital
Jin-Ok Jeong
Department of Internal Medicine, Chungnam National University Hospital
Shung Chull Chae
Department of Internal Medicine, School of Medicine, Kyungpook National University
Ki Dong Yoo
Department of Internal Medicine, The Catholic University of Korea, ST. Vincent’s Hospital
Young Jin Choi
Department of Internal Medicine, Sejong Hospital
Yong Hwan Park
Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine
Cheol-Ho Kim
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
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.
