Trial Profile

A Multi-center/Multi-national, Randomized, Controlled, Single-blind, Group Comparison Phase 3 Study to Determine the Efficacy and Safety of Gadobutrol 1.0 Molar in Comparison to Magnevist Following Single Injection in Patients Referred for Contrast-enhanced MRI of the Body/Extremities Regions (Breast, Heart, Abdomen, Kidney, Pelvis, or Extremities)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 31 Mar 2015

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At a glance

Drugs Gadobutrol (Primary) ; Gadopentetic acid
Indications Breast disorders; Gastrointestinal disorders; Heart disorders; Kidney disorders; Urogenital abnormalities
Focus Diagnostic use
Sponsors Bayer

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

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