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
  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
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, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Iobitridol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014