Trial Condition(s):

Magnetic Resonance Imaging

Contrast-enhanced MRI in children 2 months to <2 years

Bayer Identifier:

91784

ClinicalTrials.gov Identifier:

NCT00937391

EudraCT Number:

2009-013081-17

Study Completed

Trial Purpose

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

Inclusion Criteria
- Age: 2 months to < 2 years (23 months)
 - Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
 - Able to comply with the study procedures
Exclusion Criteria
- Clinical unstable participants (eg, intensive care unit)
 - Renal Insufficiency
 - Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Magnevist.

Trial Summary

Enrollment Goal
54
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Akron Children's Hospital

Akron, United States, 44308

Status
Terminated
 
Locations

Mallinckrodt Institute of Radiology

St. Louis, United States, 63110

Status
Completed
 
Locations

University of California, San Diego

San Diego, United States, 92123

Status
Terminated
 
Locations

Children's Memorial Hospital

Chicago, United States, 60614

Status
Terminated
 
Locations

University of Iowa Hospitals & Clinics

Iowa City, United States, 52242

Status
Terminated
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06120

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Texas Children's Hospital

Houston, United States, 77030

Status
Completed
 
Locations

The Children's Hospital

Aurora, United States, 80045

Status
Completed
 
Locations

Children's Mercy Hospital

Kansas City, United States, 64108-9898

Status
Completed
 
Locations

Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033

Status
Terminated
 

Trial Design