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

Bayer logo

Bayer

Status and phase

Completed
Phase 3

Conditions

Vascular Diseases

Treatments

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00395733
309762 (Other Identifier)
91537

Details and patient eligibility

About

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.

Full 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.

Enrollment

83 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chinese origin
  • Known or suspected blood vessel diseases

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

83 participants in 2 patient groups

Gadobutrol, then Gadopentate dimeglumine
Experimental group
Description:
Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged
Treatment:
Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadopentate, dimeglumine then Gadobutrol
Experimental group
Description:
Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged
Treatment:
Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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