A Randomized, Double-Blind, Placebo-Controlled Escalating Dose Phase I Interaction Study to Evaluate the Pharmacokinetics, Tolerability and Pharmacodynamics of Three Dose Levels of Debio 0614 (Istaroxime) as a 24-Hour Constant Rate IV Infusion in Combination With Chronic Oral Digoxin Treatment in Patients With Controlled Cardiac Failure and Decreased Left Ventricular Systolic Function.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Escalating Dose Phase I Interaction Study to Evaluate the Pharmacokinetics, Tolerability and Pharmacodynamics of Three Dose Levels of Debio 0614 (Istaroxime) as a 24-Hour Constant Rate IV Infusion in Combination With Chronic Oral Digoxin Treatment in Patients With Controlled Cardiac Failure and Decreased Left Ventricular Systolic Function.

Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 01 Dec 2014

At a glance

  • Drugs Istaroxime (Primary) ; Digoxin
  • Indications Heart failure; Left ventricular dysfunction
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Debiopharm
  • Most Recent Events

    • 04 Nov 2009 Status changed from not yet recruiting to withdrawn prior to recruitment as reported by ClinicalTrials.gov.
    • 07 Apr 2009 New trial record
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