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A 36-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

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Trial Profile

A 36-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Jul 2023

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At a glance

  • Drugs Sacubitril/valsartan (Primary) ; Valsartan
  • Indications Chronic heart failure
  • Focus Registrational; Therapeutic Use
  • Acronyms PARAMOUNT; PARAMOUNT-HF
  • Sponsors Novartis

Most Recent Events

  • 01 Jun 2023 Results assessing whether treating patients with heart failure with preserved ejection fraction with sacubitril/valsartan would significantly improve GLS and GCS compared with valsartan alone, published in the Journal of Cardiac Failure
  • 15 Dec 2020 According to a Novartis media release, based on the data from PARAGON-HF, PARAMOUNT and PARADIGM-HF studies, the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF).
  • 01 Apr 2014 Results published in the European Journal of Heart Failure.

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