Ultravist 370 mgI/ml: Safety and Efficacy in Computed Tomography of Head and Body - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00244140

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.

Condition	Intervention	Phase
Computed Tomography Diagnostic Imaging	Drug: Ultravist	Phase III

MedlinePlus related topics: CT Scans

Drug Information available for: Iopromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Bayer:

Primary Outcome Measures:

The quality of the Ultravist enhanced CT images of the head and/or body based on the investigator's assessment [ Time Frame: within 24 hrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The ability to make a diagnosis with the Ultravist enhanced images of the head and/or body based on the investigator's assessment [ Time Frame: within 24 hrs ] [ Designated as safety issue: Yes ]
The quality of visualization of the contrast enhanced images as assessed by the investigator [ Time Frame: within 24 hrs ] [ Designated as safety issue: Yes ]
The ability of the investigator to make a diagnosis using the contrast enhanced images [ Time Frame: within 24 hrs ] [ Designated as safety issue: Yes ]

Enrollment:	430
Study Start Date:	October 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Ultravist Ultravist 370 mg I / ml in CT of head & body, Injection

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244140

Locations

United States, Arizona

Tucson, Arizona, United States, 85711
United States, Florida

Tallahassee, Florida, United States, 32308

Miami, Florida, United States, 33136
United States, Georgia

Atlanta, Georgia, United States, 30303

Atlanta, Georgia, United States, 30365
United States, Maryland

Baltimore, Maryland, United States, 21287
United States, Massachusetts

Boston, Massachusetts, United States, 02115

Boston, Massachusetts, United States, 02114-2696

Boston, Massachusetts, United States, 02118
United States, Michigan

Detroit, Michigan, United States, 48201

Ann Arbor, Michigan, United States, 48109-0022
United States, New York

New York, New York, United States, 10016

Stony Brook, New York, United States, 11794-8460
United States, Ohio

Cleveland, Ohio, United States, 44195
United States, Pennsylvania

Danville, Pennsylvania, United States, 17822
United States, South Carolina

Charleston, South Carolina, United States, 29425
India

Tamil Nadu, India

Mumbai-400026, India
Korea, Republic of

Seoul, Korea, Republic of, 138-736

Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	91462, 309660
Study First Received:	October 24, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00244140
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Ultravist 370
CECT
CT Scan

ClinicalTrials.gov processed this record on January 16, 2009