CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 402 enrolled
Drug / intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875) +1 moredrug
Likely dose
Not stated in 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.

Search/NCT00709852
NCT00709852Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Crossover, 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)

Bayer·interventional·Posted Jul 3, 2008·Updated Dec 30, 2014

In Brief

A Phase 3 clinical trial evaluating Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Gadoteridol (ProHance) for Diagnostic Imaging and Central Nervous System Diseases. Completed, enrolled 402 participants across 79 sites in 8 countries.

Detailed Summary

This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiagnostic Imaging, Central Nervous System Diseases
CountriesAustralia, Austria, Colombia, Germany, India, Japan, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 3, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.0 years ago

Interventions

Gadobutrol (Gadavist, Gadovist, BAY86-4875)drug

Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)

Gadoteridol (ProHance)drug

Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.