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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

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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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Sacubitril/valsartan (Primary) ; Enalapril
  • Indications Chronic heart failure; Heart failure
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms PANORAMA-HF
  • Sponsors Novartis; Novartis Pharma KK; Novartis Pharmaceuticals

Most Recent Events

  • 31 Mar 2023 According to a Novartis media release, based on data from PANORAMA-HF trial, the largest pediatric heart failure study ever conducted, and extrapolation of adult heart failure data from the Phase III PARADIGM-HF trial to pediatric patients; the EMA Committee for CHMP has adopted a positive opinion recommending approval of Entresto for a new indication to treat symptomatic chronic heart failure with left ventricular systolic dysfunction in pediatric patients aged from 1 to <18 years.
  • 01 Mar 2023 Results (n=375) assessing the effects of sacubitril/valsartan on clinical outcomes in pediatric patients with heart failure, published in the Circulation: Heart Failure.
  • 05 Apr 2022 Status changed from active, no longer recruiting to completed.

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