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
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
- 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.