Overview of the iopentol phase 2 and 3 clinical trial programme

The aim of the clinical trial programme planned for iopentol (Nycomed AS, Oslo, Norway) was to evaluate the effects of this non-ionic contrast medium in the main vascular examinations, requiring contrast medium. The programme, coordinated by Nycomed AS, covers the use of iopentol in CT-enhancements, urography, phlebography, cardioangiography, cerebral and peripheral arteriography in adults. Altogether, 26 Phase II and III clinical trials were performed. A total of 1907 patients were allocated to the trials and 33 were excluded (none due to adverse events). The included patient material consists of 1028 patients examined with iopentol and 937 patients examined with various non-ionic or ionic contrast media. (author). 17 refs.; 2 figs.; 3 tabs