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

PHASE3CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
Vascular Diseases
Interventions
DRUG

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

DRUG

Gadopentate dimeglumine (Magnevist, BAY86-4882)

Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

Trial Locations (3)

100853

Beijing

200025

Shanghai

610041

Chengdu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY