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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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اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • معلومة اضافية
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: [London] : BioMed Central, 2006-
    • الموضوع:
      Angiotensin II Type 1 Receptor Blockers/*therapeutic use ; Angiotensin-Converting Enzyme Inhibitors/*therapeutic use ; Antihypertensive Agents/*therapeutic use ; Biphenyl Compounds/*therapeutic use ; Blood Pressure/*drug effects ; Diuretics/*therapeutic use ; Essential Hypertension/*drug therapy ; Perindopril/*therapeutic use ; Pyrimidines/*therapeutic use ; Tetrazoles/*therapeutic use; Age Factors ; Aged ; Aged, 80 and over ; Angiotensin II Type 1 Receptor Blockers/adverse effects ; Angiotensin-Converting Enzyme Inhibitors/adverse effects ; Antihypertensive Agents/adverse effects ; Biphenyl Compounds/adverse effects ; Clinical Trials, Phase III as Topic ; Diuretics/adverse effects ; Double-Blind Method ; Drug Therapy, Combination ; Equivalence Trials as Topic ; Essential Hypertension/diagnosis ; Essential Hypertension/physiopathology ; Female ; Humans ; Male ; Multicenter Studies as Topic ; Perindopril/adverse effects ; Pyrimidines/adverse effects ; Republic of Korea ; Tetrazoles/adverse effects ; Time Factors ; Treatment Outcome
    • نبذة مختصرة :
      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.
    • References:
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      Arch Gerontol Geriatr. 2005 Sep-Oct;41(2):141-9. (PMID: 16085065)
      N Engl J Med. 2008 May 1;358(18):1887-98. (PMID: 18378519)
      Ther Adv Cardiovasc Dis. 2008 Jun;2(3):167-77. (PMID: 19124420)
      BMJ. 2011 Jan 04;344:d7541. (PMID: 22218098)
      Clin Ther. 2012 Mar;34(3):552-568, 568.e1-9. (PMID: 22381711)
      Hypertension. 2014 Mar;63(3):433-41. (PMID: 24324042)
      JAMA. 2014 Feb 5;311(5):507-20. (PMID: 24352797)
      Curr Ther Res Clin Exp. 2013 Jun;74:54-61. (PMID: 24384734)
      Eur J Phys Rehabil Med. 2014 Dec;50(6):693-701. (PMID: 25077426)
      Clin Ther. 2014 Oct 1;36(10):1412-21. (PMID: 25092393)
      BMC Med. 2015 Jul 13;13:161. (PMID: 26166298)
      Korean J Intern Med. 2016 May;31(3):594-600. (PMID: 26701231)
      JAMA. 2016 Jun 28;315(24):2673-82. (PMID: 27195814)
      Sci Rep. 2017 Aug 8;7(1):7542. (PMID: 28790349)
    • Grant Information:
      200125 Boryung Pharmaceutical Co., Ltd
    • Contributed Indexing:
      Keywords: Elderly; Essential hypertension; Fimasartan; Frail elderly; Hypertension; Perindopril; Treatment
    • Molecular Sequence:
      ClinicalTrials.gov NCT03246555
    • الرقم المعرف:
      0 (Angiotensin II Type 1 Receptor Blockers)
      0 (Angiotensin-Converting Enzyme Inhibitors)
      0 (Antihypertensive Agents)
      0 (Biphenyl Compounds)
      0 (Diuretics)
      0 (Pyrimidines)
      0 (Tetrazoles)
      P58222188P (fimasartan)
      Y5GMK36KGY (Perindopril)
    • الموضوع:
      Date Created: 20190703 Date Completed: 20200224 Latest Revision: 20200225
    • الموضوع:
      20250114
    • الرقم المعرف:
      PMC6604456
    • الرقم المعرف:
      10.1186/s13063-019-3466-5
    • الرقم المعرف:
      31262348