Contrast-enhanced MRI in Children 2 Months to <2 Years

PHASE3CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Magnetic Resonance Imaging
Interventions
DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-6661)

For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).

Trial Locations (13)

17033

Hershey

24105

Kiel

44308

Akron

52242

Iowa City

60614

Chicago

63110

St Louis

77030

Houston

80045

Aurora

92123

San Diego

64108-9898

Kansas City

01307

Dresden

06120

Halle

07740

Jena

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00937391 - Contrast-enhanced MRI in Children 2 Months to <2 Years | Biotech Hunter | Biotech Hunter