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

Diagnostic Imaging Clinical Trial

Official title:

A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382317
• Other study ID #: ISO-44-009
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2006
• Last updated: November 25, 2008
• Start date: August 2006
• Est. completion date: February 2008

Study information

• Verified date: November 2008
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Drug:
• Iobitridol

Locations

Country	Name	City	State
Austria	AKH	Vienna
France	CHU Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

Austria,  France,