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A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00382317
First Posted: September 29, 2006
Last Update Posted: November 26, 2008
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:
Guerbet
  Purpose
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.

Condition Intervention Phase
Diagnostic Imaging Drug: Iobitridol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications

Further study details as provided by Guerbet:

Study Start Date: August 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female having reached legal majority age and up to 85 years included.
  • Scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pre-therapeutic evaluation or for post-surgical control or follow-up (including patients with prosthetic vascular material).
  • Female of childbearing potential must have effective contraception (contraceptive pill or intra-uterine device), or be surgically sterilised, or post-menopausal (minimum 12 months amenorrhea) or must have a documented negative urine and/or blood pregnancy test at screening.

Exclusion Criteria:

  • Patients with overt non-compensated heart failure.
  • Patients with hemodynamic instability.
  • Patients with ESC (European Society of Cardiology)/ESH (European Society of Hypertension) grade 3 hypertension (SBP [systolic blood pressure) over or equal to 180 mm Hg or DBP [diastolic blood pressure] over or equal to 110 mm Hg)
  • Patients with known severe renal failure (defined as creatinine clearance < 30 ml/min as calculated by the Cockroft and Gault formula).
  • Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
  • Patients with known thyreotoxicosis.
  • Patients with history of immediate or delayed major hypersensitivity reaction to iodinated contrast media.
  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): NCT00382317


Locations
Austria
AKH
Vienna, Austria, 1090
France
CHU Charles Nicolle
Rouen, France, 76031
Sponsors and Collaborators
Guerbet
Investigators
Study Chair: Corinne Dubourdieu, PhD Guerbet
  More Information

ClinicalTrials.gov Identifier: NCT00382317     History of Changes
Other Study ID Numbers: ISO-44-009
First Submitted: September 28, 2006
First Posted: September 29, 2006
Last Update Posted: November 26, 2008
Last Verified: November 2008

Keywords provided by Guerbet:
MSCT indications


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