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

Bayer logo

Bayer

Status and phase

Completed
Phase 3

Conditions

Diagnostic Imaging
Computed Tomography

Treatments

Drug: Iopromide 370 mg I/mL
Drug: Iopromide 300 mg I/mL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00244140
91462
309660 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

435 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

435 participants in 2 patient groups

Iopromide 370 mg I/mL
Experimental group
Description:
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Treatment:
Drug: Iopromide 370 mg I/mL
Iopromide 300 mg I/mL
Experimental group
Description:
Iopromide (Ultravist 300 mg I/mL) administered intravenously
Treatment:
Drug: Iopromide 300 mg I/mL

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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