Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

PHASE3CompletedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Diagnostic ImagingCentral Nervous System Diseases
Interventions
DRUG

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)

DRUG

Gadoteridol (ProHance)

Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.

Trial Locations (79)

1090

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken, Vienna

1211

Hôpital Cantonal Universitaire de Genève, Geneva

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

2217

St George Hospital, Kogarah

3010

Inselspital Bern, Bern

3168

Monash Medical Centre, Clayton

3430

Landeskrankenhaus Donauregion Tulln, Tulln

4020

LNK Wagner Jauregg, Linz

4031

Universitätsspital Basel, Basel

6000

Luzerner Kantonsspital, Lucerne

8036

Medizinische Universität Graz, Graz

9007

Kantonsspital St. Gallen, Sankt Gallen

10003

NYU Hospital for Joint Diseases, New York

10117

Universitätsklinikum Charite zu Berlin, Berlin

12401

Kingston Neurological Associates, PC, Kingston

14467

Klinikum Ernst von Bergmann, Potsdam

15212

Allegheny General Hospital, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

20246

Universitätsklinikum Hamburg Eppendorf (UKE), Hamburg

21201

University of Maryland Hospital System, Baltimore

21287

Johns Hopkins Hospital/Health System, Baltimore

24105

Klinikum der Christian-Albrechts-Universität, Kiel

27707

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30625

Kliniken der Medizinischen Hochschule Hannover, Hanover

32209

University of Florida - Jacksonville, Jacksonville

35209

West Alabama Research, Inc., Birmingham

35406

Achieve Clinical Research, LLC, Tuscaloosa

44195

The Cleveland Clinic, Cleveland

44263

Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock, Dortmund

50937

Universitätsklinikum Köln, Cologne

53105

Medizinische Einrichtungen der Universität Bonn, Bonn

53215

Aurora Saint Luke's Medical Center, Milwaukee

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

60488

Krankenhaus Nordwest, Frankfurt am Main

63110

Washington University School of Medicine, St Louis

66002

Atchison Hospital, Atchison

66424

Universitätskliniken des Saarlandes, Homburg

68167

Klinikum Mannheim gGmbH, Mannheim

69120

Deutsches Krebsforschungszentrum, Heidelberg

76133

Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe

81377

LMU Klinikum der Universität München - Großhadern, München

81675

Klinikum rechts der Isar, München

87131

University of New Mexico School of Medicine, Albuquerque

91054

Universitätsklinikum Erlangen, Erlangen

95032

Los Gatos MRI, Los Gatos

95403

Redwood Regional Medical Group, Inc., Santa Rosa

98195

University of Washington Medical Center, Seattle

99089

HELIOS Klinikum Erfurt GmbH, Erfurt

252002

CT /MRI centre, Indore

400004

Piramal Diagnostic- Jankharia Imaging, Mumbai

400020

Bombay Hospital, Institute of Medical sciences, Mumbai

865156

Zentralklinikum Augsburg, Augsburg

92658-6100

Hoag Memorial Hospital Presbyterian, Newport Beach

02301

Shields MRI - Brockton, Brockton

02132

VA Boston Healthcare System-West Roxbury Division, West Roxbury

02903

Rhode Island Hospital, Providence

Unknown

Fundación Instituto de Alta tecnología médica de Antioquia, Medellín

Fundación Santa Fe de Bogotá - Hospital Universitario, Bogotá

DIME Clinica Neurocardiovascular S.A., Santiago de Cali

Centro de Diagnostico Medico, Medellín

01307

Medizinische Fakultät Carl Gustav Carus, Dresden

04103

Universitätsklinikum Leipzig AöR, Leipzig

226 014

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

454-0933

Nagoya Kyoritsu Clinic, Nagoya

Nagoya Kyoritsu Hospital, Nagoya

457-8510

Social Insurance Chukyo Hospital, Nagoya

670-8520

Himeji Medical Center, Himeji

672-8501

Himeji Central Hospital, Himeji

650-0047

Institute of Biomedical Research and Innovation, Kobe

Kobe City Medical Center General Hospital, Kobe

654-0047

Shinsuma Hospital, Kobe

616-8255

Utano National Hospital, Kyoto

596-8522

Kishiwada Tokushukai Hospital, Kishiwada

537-8511

Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka

540-0006

Osaka National Hospital, Osaka

558-8558

Osaka General Medical Center, Osaka

750-0061

Shimonoseki Kosei Hospital, Shimonoseki

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00709852 - Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging | Biotech Hunter | Biotech Hunter