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

Sponsored by:	Guerbet
Information provided by:	Guerbet
ClinicalTrials.gov Identifier:	NCT00382317

Purpose

This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.

Condition	Intervention	Phase
Diagnostic Imaging	Drug: Iobitridol	Phase IV

Drug Information available for: Iobitridol

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Sponsors and Collaborators

Guerbet

Investigators

Study Chair:

Corinne Dubourdieu, PhD

Guerbet

More Information

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

Keywords provided by Guerbet:

MSCT indications

ClinicalTrials.gov processed this record on January 14, 2009