At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 enrolled
Drug / intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875)drug
Likely dose
Gadobutrol (Gadavist, Gadovist, BAY86-4875) 2mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS).
In Brief
A Phase 3 clinical trial evaluating Gadobutrol (Gadavist, Gadovist, BAY86-4875) for Central Nervous System Diseases. Completed, enrolled 343 participants across 37 sites in 5 countries.
Detailed Summary
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Nervous System Diseases
CountriesArgentina, China, Colombia, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedFeb 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedFeb 26, 2008
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.3 years ago
Interventions
Gadobutrol (Gadavist, Gadovist, BAY86-4875)drug
Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.