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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR GADAVIST

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Clinical Trials for Gadavist

Trial ID Title Status Sponsor Phase Summary
NCT00395460 Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients Completed Bayer Phase 3 The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
NCT00395733 Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients Completed Bayer Phase 3 The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
NCT00468819 A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children Completed Bayer Phase 1 In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gadavist

Condition Name

Condition Name for Gadavist
Intervention Trials
Central Nervous System Diseases 3
Magnetic Resonance Imaging 2
Coronary Artery Disease 2
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Condition MeSH

Condition MeSH for Gadavist
Intervention Trials
Brain Neoplasms 3
Nervous System Diseases 3
Myocardial Ischemia 3
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Clinical Trial Locations for Gadavist

Trials by Country

Trials by Country for Gadavist
Location Trials
United States 81
Germany 29
Colombia 10
Korea, Republic of 9
China 8
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Trials by US State

Trials by US State for Gadavist
Location Trials
California 6
South Carolina 5
Pennsylvania 5
New York 5
Missouri 5
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Clinical Trial Progress for Gadavist

Clinical Trial Phase

Clinical Trial Phase for Gadavist
Clinical Trial Phase Trials
Phase 4 4
Phase 3 7
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Gadavist
Clinical Trial Phase Trials
Completed 11
Not yet recruiting 4
Enrolling by invitation 1
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Clinical Trial Sponsors for Gadavist

Sponsor Name

Sponsor Name for Gadavist
Sponsor Trials
Bayer 9
University of Missouri-Columbia 1
Cedars-Sinai Medical Center 1
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Sponsor Type

Sponsor Type for Gadavist
Sponsor Trials
Industry 11
Other 7
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Colorcon
Julphar
Boehringer Ingelheim
Fish and Richardson
Federal Trade Commission
Cantor Fitzgerald
Argus Health
Covington

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