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Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

NCT00623467 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2014-02-10

Study results available
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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.

Conditions

Interventions

DRUG

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Argentina
  • China
  • Colombia
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00623467 on ClinicalTrials.gov