Woman and Man
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Extract
To determine the optimal dose of ivabradine to reach the target heart rate reduction (HRR) of 20% without inducing a bradycardia (i.e. HR should be greater than a predefined HR threshold by age subset) and/or signs or symptoms related to bradycardia, To assess the pharmacokinetic (PK) parameters of ivabradine and its active metabolite S 18982 after repeated oral administrations, To assess the PKPD relationship of ivabradine and its active metabolite S 18982 using heart rate as evaluation criterion.
Inclusion criteria
- Paediatric dilated cardiomyopathy and symptomatic chronic heart failure