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

This study has been completed.
Sponsor:
Information provided by:
Guerbet
ClinicalTrials.gov Identifier:
NCT00382317
First received: September 28, 2006
Last updated: November 25, 2008
Last verified: November 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00382317     History of Changes
Other Study ID Numbers: ISO-44-009
Study First Received: September 28, 2006
Last Updated: November 25, 2008
Health Authority: European Union: European Medicines Agency

Keywords provided by Guerbet:
MSCT indications

ClinicalTrials.gov processed this record on May 16, 2013