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

Diagnostic Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244140
• Other study ID #: 91462
• Secondary ID: 309660
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2005
• Last updated: January 28, 2014
• Start date: October 2005
• Est. completion date: April 2008

Study information

• Verified date: January 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Computed Tomography
• Diagnostic Imaging

Intervention

Drug:
• Iopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
• Iopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Colombia,  India,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.	A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.	post administration assessment of study images	No
Secondary	The Ability of the Investigator to Make a Diagnosis Based on the CECT Images	The number of participants with diagnostic CECTs as assessed by the investigators.	post administration assessment of study images	No
Secondary	The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.	A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.	post administration assessment of study images	No
Secondary	The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images	The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.	post administration assessment of study images	No

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