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An open label randomized, 3-arm, parallel-group, placebo and eplerenone controlled study to evaluate the mineralocorticoid receptor antagonism (MRA) effect of vamorolone in healthy adult male subjects after challenge with fludrocortisone

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Trial Profile

An open label randomized, 3-arm, parallel-group, placebo and eplerenone controlled study to evaluate the mineralocorticoid receptor antagonism (MRA) effect of vamorolone in healthy adult male subjects after challenge with fludrocortisone

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Oct 2024

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At a glance

  • Drugs Vamorolone (Primary) ; Eplerenone
  • Indications Duchenne muscular dystrophy
  • Focus Therapeutic Use
  • Acronyms LIONHEART

    • Most Recent Events

    • 08 Oct 2024 New trial record
    • 01 Oct 2024 According to Santhera Pharmaceuticals media release, further analysis of the data is ongoing and will be presented at medical conferences.
    • 01 Oct 2024 Primary endpoint (ratio of sodium to potassium (Na/K) and the corresponding logarithm of the ratio (log10(10*Na/K) in urine at different time-points.) has been met as per Santhera media release

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