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Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years. A randomised, double-blind, multicentre, placebo controlled, phase II/III dose-finding study with a PK/PD characterisation and a 1 year efficacy/safety evaluation.

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Trial Profile

Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years. A randomised, double-blind, multicentre, placebo controlled, phase II/III dose-finding study with a PK/PD characterisation and a 1 year efficacy/safety evaluation.

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Oct 2021

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At a glance

  • Drugs Ivabradine (Primary)
  • Indications Chronic heart failure
  • Focus Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Sponsors IRIS
  • Most Recent Events

    • 30 Sep 2013 Status changed from recruiting to completed as reported by ISRCTN: Current Controlled Trials.
    • 17 Mar 2012 Additional lead trial investigator identified as reported by United Kingdom Clinical Research Network.
    • 17 Mar 2012 New source identified and integrated (United Kingdom Clinical Research Network; 10291).
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