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

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Sep 2016

At a glance

  • Drugs Rolofylline (Primary)
  • Indications Acute heart failure; Renal impairment
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms PROTECT-1
  • Sponsors NovaCardia
  • Most Recent Events

    • 22 Sep 2016 Results of a retrospective analysis from PROTECT-1 and PROTECT-2 studies published in the Heart.
    • 18 Aug 2012 Additional locations (United Kingdom and Spain) added as reported by European Clinical Trials Database record.
    • 18 Aug 2012 Planned number of patients changed from 920 to 1000 as reported by European Clinical Trials Database record.
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