Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2010-01-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Arm 1
Gadobutrol (Gadovist, BAY86-4875)
Single administration at a dose of 0.1 mmol/kg
Arm 2
Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
Single administration at a dose of 0.1 mmol/kg
Interventions
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Gadobutrol (Gadovist, BAY86-4875)
Single administration at a dose of 0.1 mmol/kg
Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
Single administration at a dose of 0.1 mmol/kg
Eligibility Criteria
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Inclusion Criteria
* Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure
* Is willing to undergo the routine contrast-enhanced MRI examinations
* Is willing and able to complete all study procedures specified in the protocol
* Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist
Exclusion Criteria
* Has received any investigational product or has participated in any other clinical trial within 2 weeks prior to enrolling in this study
* Has been previously enrolled in this study or any other study using gadobutrol
* Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
* Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
* Has received any contrast agent within 24 hours prior to the study MRI
* Has a glomerular filtration rate value \<30 mL/min/1.73m2 derived from a serum creatinine result within 4 weeks prior to study enrollment
* Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure)
* Has severe cardiovascular disease (eg, acute myocardial infarction (\<14 days), unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\<48 hours)
* Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
* Has any contraindication to Magnevist according to the package insert
20 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Xi’an, Shanxi, China
Beijing, , China
Shanghai, , China
Shanghai, , China
Kamogawa, Chiba, Japan
Matsuyama, Ehime, Japan
Chikushino-shi, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Kobe, Hyōgo, Japan
Sunto, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Seoul, , South Korea
Seoul, , South Korea
Countries
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Other Identifiers
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13297
Identifier Type: -
Identifier Source: org_study_id