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, 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

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.

Keywords: Elderly; Essential hypertension; Fimasartan; Frail elderly; Hypertension; Perindopril; Treatment.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study overview. Abbreviations: FMS Fimasartan, HCTZ Hydrochlorothiazide, PCB Placebo, Perind Perindopril arginine, Inda Indapamide, R Randomization, S Screening
Fig. 2
Fig. 2
Time line of study procedure and outcome assessment. Abbreviations: FMS Fimasartan, HCTZ Hydrochlorothiazide, Inda Indapamide, Perind Perindopril arginine

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