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Multicenter open-label study to evaluate efficacy of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) for detection of significant coronary artery disease (CAD) in subjects with known or suspected CAD by a blinded image analysis

Trial Profile

Multicenter open-label study to evaluate efficacy of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) for detection of significant coronary artery disease (CAD) in subjects with known or suspected CAD by a blinded image analysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2019

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At a glance

  • Drugs Gadobutrol (Primary)
  • Indications Coronary artery disease
  • Focus Diagnostic use
  • Acronyms GadaCAD 1
  • Sponsors Bayer
  • Most Recent Events

    • 15 Jul 2019 According to a Bayer media release, Food and Drug Administration has approved Gadavist injection for use in cardiac magnetic resonance in adult patients with known or suspected coronary artery disease.The approval was based on two multinational, non-randomized, blinded-read Phase 3 studies(NCT01890421 and NCT01890434)
    • 03 Jun 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
    • 31 Aug 2018 Biomarkers information updated
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