Pharmacokinetics, pharmacodynamics, safety and efficacy study of LCZ696 in children (1 month to < 18 years) with heart failure

Update Il y a 4 ans
Reference: EUCTR2015-004207-22

Woman and Man

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Extract

This study consist of two parts (Part 1 and Part 2). Part 1: to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. Part 2: to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.


Inclusion criteria

  • Pediatric heart failure 1 month to <18 years old