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

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)

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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