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Phase IB Double Blind, Randomized, Placebo Controlled Clinical Trial to Determine the Pharmacokinetics and Safety of a Revised Protocol of Intravenous L-Citrulline (Citrupress®) Versus Placebo in Children Undergoing Cardiopulmonary Bypass

Trial Profile

Phase IB Double Blind, Randomized, Placebo Controlled Clinical Trial to Determine the Pharmacokinetics and Safety of a Revised Protocol of Intravenous L-Citrulline (Citrupress®) Versus Placebo in Children Undergoing Cardiopulmonary Bypass

Completed
Phase of Trial: Phase I/II

Latest Information Update: 13 Dec 2017

At a glance

  • Drugs Citrulline (Primary)
  • Indications Acute lung injury
  • Focus Therapeutic Use
  • Sponsors Asklepion Pharmaceuticals
  • Most Recent Events

    • 13 Dec 2017 New trial record
    • 08 Dec 2017 According to an Asklepion Pharmaceuticals media release, results from this trial were presented at the Pediatric Cardiac Intensive Care Society (PCICS) 13th Annual International Meeting.
    • 08 Dec 2017 Primary endpoint (To determine if L-citrulline given perioperatively achieves a plasma citrulline level of 100 umol/L in children undergoing surgical repair of an atrial septal defect, a ventricular septal defect or an atrioventricular septal defect.) has been met according to an Asklepion Pharmaceuticals media release.
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