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Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease

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Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2016

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At a glance

  • Drugs Gadobutrol (Primary)
  • Indications Renal Artery Obstruction; Vascular disorders
  • Focus Diagnostic use; Registrational
  • Acronyms GRAMS
  • Sponsors Bayer

    • Most Recent Events

    • 06 May 2016 New trial record
    • 29 Apr 2016 Results published in a Bayer media release.
    • 29 Apr 2016 The US FDA has approved gadobutrol injection (Gadavist) for use with MRA to evaluate known or suspected supra-aortic or renal artery disease in adult and paediatric patients including term neonates. The approval was based on the results from this and another phase III trial (GEMSAV; CTP 700270877).

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