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A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

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Trial Profile

A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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At a glance

  • Drugs Sacubitril/valsartan (Primary) ; Enalapril; Valsartan
  • Indications Chronic heart failure; Heart failure
  • Focus Therapeutic Use
  • Acronyms PARALLAX
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharmaceuticals

Most Recent Events

  • 29 Aug 2022 Results of post-hoc analysis assessing the impact of sacubitril/valsartan on this endpoint in comparison to standard medical therapy, presented at the ESC Congress 2022 - Annual Congress of the European Society of Cardiology.
  • 16 Nov 2021 Primary endpoint has not been met (Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24) , according to Results published in the JAMA: the Journal of the American Medical Association
  • 16 Nov 2021 Amendment 2: This amendment expanded EF inclusion criteria from current greater or equal to 45percent to greater than 40percent in order to ensure that LCZ696 clinical development program will cover full EF spectrum. The amendment also included a strategy for multiplicity testing of primary and secondary efficacy endpoints.

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