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

NCT ID: NCT00244140

Last Updated: 2014-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Computed Tomography Diagnostic Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Iopromide 370 mg I/mL

Iopromide (Ultravist 370 mg I/mL) administered intravenously

Group Type EXPERIMENTAL

Iopromide 370 mg I/mL

Intervention Type DRUG

Iopromide (Ultravist 370 mg I/mL) administered intravenously

Iopromide 300 mg I/mL

Iopromide (Ultravist 300 mg I/mL) administered intravenously

Group Type EXPERIMENTAL

Iopromide 300 mg I/mL

Intervention Type DRUG

Iopromide (Ultravist 300 mg I/mL) administered intravenously

Interventions

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Iopromide 370 mg I/mL

Iopromide (Ultravist 370 mg I/mL) administered intravenously

Intervention Type DRUG

Iopromide 300 mg I/mL

Iopromide (Ultravist 300 mg I/mL) administered intravenously

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Tucson, Arizona, United States

Site Status

Miami, Florida, United States

Site Status

Tallahassee, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Atlanta, Georgia, United States

Site Status

Evanston, Illinois, United States

Site Status

Baltimore, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Detroit, Michigan, United States

Site Status

New York, New York, United States

Site Status

Stony Brook, New York, United States

Site Status

Cleveland, Ohio, United States

Site Status

Danville, Pennsylvania, United States

Site Status

Charleston, South Carolina, United States

Site Status

Medellín, Antioquia, Colombia

Site Status

Bogotá, , Colombia

Site Status

Mumbai-400026, , India

Site Status

Tamil Nadu, , India

Site Status

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Seoul, , South Korea

Site Status

Countries

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United States Colombia India South Korea

Other Identifiers

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309660

Identifier Type: OTHER

Identifier Source: secondary_id

91462

Identifier Type: -

Identifier Source: org_study_id

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