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NCT03246555: FITNESS

Fimasartan in the Senior Subjects

Completed Phase 3 Last updated 23 March 2020
What this trial tests

Phase 3 trial testing Fimasartan or Fimasartan/Hydrochlorothiazide in The Elderly (≥ 70 Years) With Essential Hypertension in 241 participants. Completed in 9 December 2019.

Timeline
15 July 2016
Primary endpoint
19 August 2019
9 December 2019

Quick facts

Lead sponsorBoryung Pharmaceutical Co., Ltd
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment241
Start date15 July 2016
Primary completion19 August 2019
Estimated completion9 December 2019
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Boryung Pharmaceutical Co., Ltd — full company profile →

Who can join

70 and older, any sex, with The Elderly (≥ 70 Years) With Essential Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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 MG, Kim KI, Ihm SH, Rhee MY, et al · · 2019 · cited 3× · PMID 31262348 · DOI 10.1186/s13063-019-3466-5
  2. A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hyperte
    Lee HY, Kim KI, Ihm SH, Rhee MY, et al · · 2021 · cited 1× · PMID 34503866 · DOI 10.1016/j.clinthera.2021.08.003

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