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Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study and 8-week Open Label Extension to Evaluate the Effect of Initiation of Sacubitril/Valsartan on Objective Measures of Waking Activity and Sleep, as Health-related Quality of Life Functions in Subjects With Heart Failure and Reduced Ejection Fraction (AWAKE-HF)

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Trial Profile

Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study and 8-week Open Label Extension to Evaluate the Effect of Initiation of Sacubitril/Valsartan on Objective Measures of Waking Activity and Sleep, as Health-related Quality of Life Functions in Subjects With Heart Failure and Reduced Ejection Fraction (AWAKE-HF)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 11 Jan 2022

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At a glance

  • Drugs Sacubitril/valsartan (Primary) ; Enalapril
  • Indications Heart failure
  • Focus Therapeutic Use
  • Acronyms AWAKE-HF
  • Sponsors Novartis; Novartis Pharmaceuticals Corporation
  • Most Recent Events

    • 01 Dec 2021 Results assessing the effect of treatment with sacubitril/valsartan on sleep-related endpoints, published in the Journal of Cardiac Failure.
    • 26 Sep 2020 Results published in the American Journal of Cardiovascular Drugs.
    • 18 Mar 2019 Primary endpoint has not been met. (Ratio of Mean Activity Counts Collected During the Most Active 30 Minutes of the Subjects Day Between Week 8 and Baseline)
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