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.
Phase of Trial: Phase II/III
Latest Information Update: 25 Sep 2014
At a glance
- Drugs Ivabradine (Primary)
- Indications Chronic heart failure; Dilated cardiomyopathy
- Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
- Sponsors IRIS
- 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).