NCT00244140

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

Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Computed Tomography
• Diagnostic Imaging

Interventions

Type	Name	Description
DRUG	Iopromide 370 mg I/mL	Iopromide (Ultravist 370 mg I/mL) administered intravenously
DRUG	Iopromide 300 mg I/mL	Iopromide (Ultravist 300 mg I/mL) administered intravenously

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-10-26
• Last updated: 2014-02-28
• Results posted: 2009-07-20

Locations

23 sites across 4 countries: United States, Colombia, India, South Korea