Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2010-01-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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)).
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)).
Interventions
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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)).
Eligibility Criteria
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Inclusion Criteria
* Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
* Able to comply with the study procedures
Exclusion Criteria
* Renal Insufficiency
* Participants undergoing chemotherapy \</= 48 hours prior to and up to 24 hours after the administration of Magnevist.
2 Months
23 Months
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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San Diego, California, United States
Aurora, Colorado, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Akron, Ohio, United States
Hershey, Pennsylvania, United States
Houston, Texas, United States
Dresden, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Kiel, Schleswig-Holstein, Germany
Jena, Thuringia, Germany
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2009-013081-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
312046
Identifier Type: OTHER
Identifier Source: secondary_id
91784
Identifier Type: -
Identifier Source: org_study_id