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
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
Trials - 20(2019), 1 vom: 01. Juli, Seite 389 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kang, Min-Gu [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 24.02.2020 Date Revised 25.02.2020 published: Electronic ClinicalTrials.gov: NCT03246555 Citation Status MEDLINE |
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| doi: |
10.1186/s13063-019-3466-5 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM298760908 |
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| 100 | 1 | |a Kang, Min-Gu |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)) |b study protocol for a randomized controlled trial |
| 264 | 1 | |c 2019 | |
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| 500 | |a Date Completed 24.02.2020 | ||
| 500 | |a Date Revised 25.02.2020 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03246555 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03246555 , registered on July 25, 2017 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Elderly | |
| 650 | 4 | |a Essential hypertension | |
| 650 | 4 | |a Fimasartan | |
| 650 | 4 | |a Frail elderly | |
| 650 | 4 | |a Hypertension | |
| 650 | 4 | |a Perindopril | |
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| 650 | 7 | |a Biphenyl Compounds |2 NLM | |
| 650 | 7 | |a Diuretics |2 NLM | |
| 650 | 7 | |a Pyrimidines |2 NLM | |
| 650 | 7 | |a Tetrazoles |2 NLM | |
| 650 | 7 | |a fimasartan |2 NLM | |
| 650 | 7 | |a P58222188P |2 NLM | |
| 650 | 7 | |a Perindopril |2 NLM | |
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| 700 | 1 | |a Kim, Kwang-Il |e verfasserin |4 aut | |
| 700 | 1 | |a Ihm, Sang Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Rhee, Moo-Yong |e verfasserin |4 aut | |
| 700 | 1 | |a Sohn, Il Suk |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Hae-Young |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Sungha |e verfasserin |4 aut | |
| 700 | 1 | |a Jeon, Eun-Seok |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Jong-Min |e verfasserin |4 aut | |
| 700 | 1 | |a Pyun, Wook Bum |e verfasserin |4 aut | |
| 700 | 1 | |a Sung, Ki-Chul |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Moo Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Sang-Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Seok-Yeon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Shin-Jae |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Eung Ju |e verfasserin |4 aut | |
| 700 | 1 | |a Shin, Jinho |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Sung Yun |e verfasserin |4 aut | |
| 700 | 1 | |a Chun, Kook-Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Jeong, Jin-Ok |e verfasserin |4 aut | |
| 700 | 1 | |a Chae, Shung Chull |e verfasserin |4 aut | |
| 700 | 1 | |a Yoo, Ki Dong |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Young Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Yong Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Cheol-Ho |e verfasserin |4 aut | |
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