At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 147 enrolled
Drug / intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875) +1 moredrug
Likely dose
Gadobutrol (Gadavist, Gadovist, BAY86-4875) 0,1 mlfrom 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 Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients
In Brief
A Phase 3 clinical trial evaluating Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Magnevist for Central Nervous System Diseases. Completed, enrolled 147 participants across 4 sites.
Detailed Summary
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Nervous System Diseases
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedNov 2006
Primary CompletionApr 2007
TodayJul 2026
First PostedNov 3, 2006
Enrollment StartSep 1, 2006
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.7 years ago
Interventions
Gadobutrol (Gadavist, Gadovist, BAY86-4875)drug
1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)
Magnevistdrug
0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)