A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography
This study has been completed.
Information provided by:
First received: September 28, 2006
Last updated: November 25, 2008
Last verified: November 2008
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
||A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382317
|Vienna, Austria, 1090 |
|CHU Charles Nicolle
|Rouen, France, 76031 |
||Corinne Dubourdieu, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2006
||November 25, 2008
||European Union: European Medicines Agency
Keywords provided by Guerbet:
ClinicalTrials.gov processed this record on May 16, 2013