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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of KW-3902 Injectable Emulsion on Heart Failure Signs and Symptoms and Renal Function in Subjects With Acute Heart Failure Syndrome and Renal Impairment Who Are Hospitalized for Volume Overload and Require Intravenous Diuretic Therapy

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of KW-3902 Injectable Emulsion on Heart Failure Signs and Symptoms and Renal Function in Subjects With Acute Heart Failure Syndrome and Renal Impairment Who Are Hospitalized for Volume Overload and Require Intravenous Diuretic Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2023

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At a glance

  • Drugs Rolofylline (Primary)
  • Indications Acute heart failure; Renal impairment
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms PROTECT-2
  • Sponsors NovaCardia
  • Most Recent Events

    • 17 Nov 2021 Data from RELAX-AHF-2 & PROTECT-1 & PROTECT-2 assessing interaction between diuretic response and worsening renal function (WRF) on clinical outcomes in patients with AHF, published in the European Journal of Heart Failure.
    • 05 Jun 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
    • 22 Sep 2016 Results of a retrospective analysis from PROTECT-1 and PROTECT-2 studies published in the Heart.
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