A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Trial Profile

A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2015

At a glance

  • Drugs Gadobutrol (Primary)
  • Indications Cerebrovascular disorders; Vascular disorders
  • Focus Diagnostic use; Registrational
  • Sponsors Bayer
  • Most Recent Events

    • 26 Mar 2015 According to Bayer Healthcare media release, gadobutrol injection [Gadovis] has received regulatory approval in Japan for contrast-enhancement MRI in cranial, spinal, the body and extremeties at a dose of 0.1 mL/kg body weight.
    • 11 May 2014 New trial record
    • 30 Sep 2013
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