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Protocol 156-03-236: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure

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Trial Profile

Protocol 156-03-236: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2022

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At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Chronic heart failure; Heart failure
  • Focus Therapeutic Use
  • Acronyms EVEREST
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 01 Jul 2022 Results of a post-hoc analysis assessing rates of reversal of volume overload in patients hospitalized for acute HF over 10 months of median follow-up period published in the American Journal of Kidney Diseases
    • 23 Apr 2022 Using data (n=4133) of patients from this study was used to assess the the association between rates of in-hospital change in assessments of volume overload, including b-type natriuretic peptide (BNP), N-terminal pro b-type natriuretic peptide (NT-proBNP), as well as change in hemoconcentration, with risk of all-cause mortality and a composite outcome of cardiovascular mortality or heart failure hospitalization,published in the American Journal of Medicine
    • 28 May 2018 Chronic-heart-failure and Heart-failure are retained according to inclusion criteria.
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