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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244140
First Posted: October 26, 2005
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose

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


Condition Intervention Phase
Computed Tomography Diagnostic Imaging Drug: Iopromide 370 mg I/mL Drug: Iopromide 300 mg I/mL Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultravist 370 Milligrams of Iodine Per Milliliter (mg I/mL): Safety and Efficacy in Computed Tomography of Head and Body

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. [ Time Frame: post administration assessment of study images ]
    A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.


Secondary Outcome Measures:
  • The Ability of the Investigator to Make a Diagnosis Based on the CECT Images [ Time Frame: post administration assessment of study images ]
    The number of participants with diagnostic CECTs as assessed by the investigators.

  • The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. [ Time Frame: post administration assessment of study images ]
    A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.

  • The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images [ Time Frame: post administration assessment of study images ]
    The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.


Enrollment: 435
Study Start Date: October 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Drug: Iopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
Experimental: Iopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously
Drug: Iopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244140


  Show 24 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00244140     History of Changes
Other Study ID Numbers: 91462
309660 ( Other Identifier: company internal )
First Submitted: October 24, 2005
First Posted: October 26, 2005
Results First Submitted: May 29, 2009
Results First Posted: July 20, 2009
Last Update Posted: February 28, 2014
Last Verified: January 2014

Keywords provided by Bayer:
Ultravist 370
CECT
CT Scan