Conditions: Computed Tomography Diagnostic Imaging
Keywords: Ultravist 370 CECT CT Scan
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 435
Healthy volunteers: no

Brief summary:
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:
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.

Arms:
arm 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously arm 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously

Interventions: intervention 1: Iopromide 370 mg I/mL intervention 2: Iopromide 300 mg I/mL
Intervention descriptions: intervention 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously intervention 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously

Protocol document: