NCT00937391

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

Open-label, Multi-center, Two-stage, Age Stratified, Pharmacokinetic, Safety, and Efficacy Study in Children 2 Months to < 2 Years of Age Undergoing Magnevist Injection Enhanced MRI

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 2 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to \< 2 years of age

Detailed description

Safety issues are addressed in the AE section

Conditions

• Magnetic Resonance Imaging

Interventions

Type	Name	Description
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)).

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-07-13
• Last updated: 2015-11-18
• Results posted: 2011-10-13

Locations

13 sites across 2 countries: United States, Germany