Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
NCT ID: NCT00709852
Last Updated: 2014-12-30
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
402 participants
INTERVENTIONAL
2008-06-30
2009-04-30
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
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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Gadobutrol then Gadoteridol
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Gadoteridol (ProHance)
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Gadoteridol then Gadobutrol
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Gadoteridol (ProHance)
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Interventions
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Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Gadoteridol (ProHance)
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Eligibility Criteria
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Inclusion Criteria
* Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure
* Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate
Exclusion Criteria
* Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
* Has severe cardiovascular disease (eg, known long QT syndrome, 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
18 Years
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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West Alabama Research, Inc.
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Tuscaloosa, Alabama, United States
Los Gatos MRI
Los Gatos, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Redwood Regional Medical Group, Inc.
Santa Rosa, California, United States
University of Florida - Jacksonville
Jacksonville, Florida, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Atchison Hospital
Atchison, Kansas, United States
University of Maryland Hospital System
Baltimore, Maryland, United States
Johns Hopkins Hospital/Health System
Baltimore, Maryland, United States
Shields MRI - Brockton
Brockton, Massachusetts, United States
VA Boston Healthcare System-West Roxbury Division
West Roxbury, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Kingston Neurological Associates, PC
Kingston, New York, United States
NYU Hospital for Joint Diseases
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Washington Medical Center
Seattle, Washington, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Landeskrankenhaus Donauregion Tulln
Tulln, Lower Austria, Austria
Medizinische Universität Graz
Graz, Styria, Austria
LNK Wagner Jauregg
Linz, Upper Austria, Austria
Allgemeines Krankenhaus der Stadt Wien Universitätskliniken
Vienna, Vienna, Austria
Fundación Instituto de Alta tecnología médica de Antioquia
Medellín, Antioquia, Colombia
Fundación Santa Fe de Bogotá - Hospital Universitario
Bogotá, Cundinamarca, Colombia
DIME Clinica Neurocardiovascular S.A.
Cali, Valle del Cauca Department, Colombia
Centro de Diagnostico Medico
Medellín, , Colombia
Deutsches Krebsforschungszentrum
Heidelberg, Baden-Wurttemberg, Germany
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Baden-Wurttemberg, Germany
Klinikum Mannheim gGmbH
Mannheim, Baden-Wurttemberg, Germany
Zentralklinikum Augsburg
Augsburg, Bavaria, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
LMU Klinikum der Universität München - Großhadern
München, Bavaria, Germany
Klinikum rechts der Isar
München, Bavaria, Germany
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, City state of Hamburg, Germany
Krankenhaus Nordwest
Frankfurt am Main, Hesse, Germany
Kliniken der Medizinischen Hochschule Hannover
Hanover, Lower Saxony, Germany
Medizinische Einrichtungen der Universität Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock
Dortmund, North Rhine-Westphalia, Germany
Universitätskliniken des Saarlandes
Homburg, Saarland, Germany
Medizinische Fakultät Carl Gustav Carus
Dresden, Saxony, Germany
Universitätsklinikum Leipzig AöR
Leipzig, Saxony, Germany
Klinikum der Christian-Albrechts-Universität
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Charite zu Berlin
Berlin, State of Berlin, Germany
HELIOS Klinikum Erfurt GmbH
Erfurt, Thuringia, Germany
CT /MRI centre
Indore, Madhya Pradesh, India
Piramal Diagnostic- Jankharia Imaging
Mumbai, Maharashtra, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, , India
Bombay Hospital, Institute of Medical sciences
Mumbai, , India
Nagoya Kyoritsu Clinic
Nagoya, Aichi-ken, Japan
Nagoya Kyoritsu Hospital
Nagoya, Aichi-ken, Japan
Social Insurance Chukyo Hospital
Nagoya, Aichi-ken, Japan
Himeji Medical Center
Himeji, Hyōgo, Japan
Himeji Central Hospital
Himeji, Hyōgo, Japan
Institute of Biomedical Research and Innovation
Kobe, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Shinsuma Hospital
Kobe, Hyōgo, Japan
Utano National Hospital
Kyoto, Kyoto, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, Japan
Osaka National Hospital
Osaka, Osaka, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Shimonoseki Kosei Hospital
Shimonoseki, Yamaguchi, Japan
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Hôpital Cantonal Universitaire de Genève
Geneva, Canton of Geneva, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Inselspital Bern
Bern, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
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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2007-004746-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
310123
Identifier Type: OTHER
Identifier Source: secondary_id
91681
Identifier Type: -
Identifier Source: org_study_id