Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

Last updated: May 13, 2015
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00395460
91536
309761
Project DE 00562
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chinese origin, with known or suspected brain or spine diseases

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Lactation

  • Conditions interfering with MRI

  • Allergy to any contrast agent or any drugs

  • Participation in other trial

  • Require emergency treatment

  • Severely impaired liver and kidney functions

Study Design

Total Participants: 147
Study Start date:
September 01, 2006
Estimated Completion Date:
April 30, 2007

Study Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Connect with a study center

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The 1st Affiliated Hosp of the 4th Military Med Uni

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Chinese PLA General Hosp.

    Beijing, 100853
    China

    Site Not Available

  • Fudan University Huashan Hospital

    Shanghai, 200040
    China

    Site Not Available

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