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

NCT00709852 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2014-12-30

Study results available
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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.

Conditions

Interventions

DRUG

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

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

DRUG

Gadoteridol (ProHance)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States
  • Australia
  • Austria
  • Colombia
  • Germany
  • India
  • Japan
  • Switzerland

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 NCT00709852 on ClinicalTrials.gov