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 JeongShung Chull Chae, Ki Dong Yoo, Young Jin Choi, Yong Hwan Park, Cheol Ho Kim

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number389
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 2019 Jul 1

Fingerprint

Perindopril
Diuretics
Randomized Controlled Trials
Blood Pressure
Therapeutics
Hypertension
Safety
Pharmaceutical Preparations
fimasartan
Essential Hypertension
Angiotensin Receptor Antagonists
Sample Size
Antihypertensive Agents
Arginine
Cardiovascular Diseases
Medicine
Physicians

Keywords

  • Elderly
  • Essential hypertension
  • Fimasartan
  • Frail elderly
  • Hypertension
  • Perindopril
  • Treatment

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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. / 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.

In: Trials, Vol. 20, No. 1, 389, 01.07.2019.

Research output: Contribution to journalArticle

Kang, MG, Kim, KI, Ihm, SH, Rhee, MY, Sohn, IS, Lee, HY, Park, S, Jeon, ES, Song, JM, Pyun, WB, Sung, KC, Kim, MH, Kim, SH, Kim, SY, Kim, SJ, Kim, EJ, Shin, J, Lee, SY, Chun, KJ, Jeong, JO, Chae, SC, Yoo, KD, Choi, YJ, Park, YH & Kim, CH 2019, '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, vol. 20, no. 1, 389. https://doi.org/10.1186/s13063-019-3466-5
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. / 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. In: Trials. 2019 ; Vol. 20, No. 1.
@article{459a285cb224493eaa1c2c5a6b526939,
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",
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",
author = "Kang, {Min Gu} and Kim, {Kwang Il} and Ihm, {Sang Hyun} and Rhee, {Moo Yong} and Sohn, {Il Suk} and Lee, {Hae Young} and Sungha Park and Jeon, {Eun Seok} and Song, {Jong Min} and Pyun, {Wook Bum} and Sung, {Ki Chul} and Kim, {Moo Hyun} and Kim, {Sang Hyun} and Kim, {Seok Yeon} and Kim, {Shin Jae} and Kim, {Eung Ju} and Jinho Shin and Lee, {Sung Yun} and Chun, {Kook Jin} and Jeong, {Jin Ok} and Chae, {Shung Chull} and Yoo, {Ki Dong} and Choi, {Young Jin} and Park, {Yong Hwan} and Kim, {Cheol Ho}",
year = "2019",
month = "7",
day = "1",
doi = "10.1186/s13063-019-3466-5",
language = "English",
volume = "20",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS))

T2 - Study protocol for a randomized controlled trial

AU - Kang, Min Gu

AU - Kim, Kwang Il

AU - Ihm, Sang Hyun

AU - Rhee, Moo Yong

AU - Sohn, Il Suk

AU - Lee, Hae Young

AU - Park, Sungha

AU - Jeon, Eun Seok

AU - Song, Jong Min

AU - Pyun, Wook Bum

AU - Sung, Ki Chul

AU - Kim, Moo Hyun

AU - Kim, Sang Hyun

AU - Kim, Seok Yeon

AU - Kim, Shin Jae

AU - Kim, Eung Ju

AU - Shin, Jinho

AU - Lee, Sung Yun

AU - Chun, Kook Jin

AU - Jeong, Jin Ok

AU - Chae, Shung Chull

AU - Yoo, Ki Dong

AU - Choi, Young Jin

AU - Park, Yong Hwan

AU - Kim, Cheol Ho

PY - 2019/7/1

Y1 - 2019/7/1

N2 - 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.

AB - 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.

KW - Elderly

KW - Essential hypertension

KW - Fimasartan

KW - Frail elderly

KW - Hypertension

KW - Perindopril

KW - Treatment

UR - http://www.scopus.com/inward/record.url?scp=85068452960&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85068452960&partnerID=8YFLogxK

U2 - 10.1186/s13063-019-3466-5

DO - 10.1186/s13063-019-3466-5

M3 - Article

C2 - 31262348

AN - SCOPUS:85068452960

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 389

ER -