Trial Condition(s):

Computed Tomography, Diagnostic Imaging

Ultravist: Safety and Efficacy in Computed Tomography of Head and Body

Bayer Identifier:

91462

ClinicalTrials.gov Identifier:

NCT00244140

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician.
Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body

Inclusion Criteria
- Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.
Exclusion Criteria
- Patients that are less than 18 years old and do not have a clinical indication for a contrast-enhanced CT of the head or body.

Trial Summary

Enrollment Goal
435
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Jaslok Hospital and Research Centre

Mumbai-400026, India

Status
Completed
 
Locations

John Hopkins Outpatient Center

Baltimore, United States, 21287

Status
Completed
 
Locations

Tallahassee Diagnostic Imaging

Tallahassee, United States, 32308

Status
Completed
 
Locations

NYU Langone Medical Center

New York, United States, 10016

Status
Completed
 
Locations

Brigham & Women's Hospital

Boston, United States, 02115

Status
Terminated
 
Locations

University of Miami

Miami, United States, 33101

Status
Completed
 
Locations

Boston Medical Center

Boston, United States, 02118

Status
Completed
 
Locations

Geisinger Medical Center

Danville, United States, 17822

Status
Completed
 
Locations

SUNY at Stony Brook

Stony Brook, United States, 11794-8460

Status
Completed
 
Locations

Radiology Ltd.

Tucson, United States, 85711

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Christian Medical Center & Hospital

Tamil Nadu, India

Status
Completed
 
Locations

Harper University Hospital

Detroit, United States, 48201

Status
Terminated
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109-0030

Status
Completed
 
Locations

NorthShore University HealthSystem-Evanston Hospital

Evanston, United States, 60201

Status
Terminated
 
Locations

Massachusetts General Hospital

Boston, United States, 02114-2696

Status
Completed
 
Locations

Medical University of South Carolina

Charleston, United States, 29425

Status
Completed
 
Locations

Grady Memorial Hospital

Atlanta, United States, 30303

Status
Completed
 
Locations

The Cleveland Clinic

Cleveland, United States, 44195

Status
Completed
 
Locations

Emory University

Atlanta, United States, 30322

Status
Completed
 
Locations

Fundación Cardioinfantil

Bogota, Colombia

Status
Terminated
 
Locations

Hospital Universitario de San Ignacio

Bogotá, Colombia

Status
Terminated
 
Locations

Clínica Las Vegas

Medellín, Colombia

Status
Terminated
 

Trial Design