Multicenter, Open-label, Single Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

Trial Profile

Multicenter, Open-label, Single Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Sacubitril/valsartan (Primary) ; Enalapril
  • Indications Heart failure
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 07 Mar 2017 Planned End Date changed from 1 Apr 2021 to 21 Apr 2021.
    • 07 Mar 2017 Planned primary completion date changed from 1 Apr 2021 to 21 Apr 2021.
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