At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 468 enrolled
Drug / intervention
iobitridol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)
In Brief
A Phase 4 clinical trial evaluating iobitridol, iopromide, and 1 other intervention for Coronary Artery Disease. Completed, enrolled 468 participants across 23 sites in 5 countries.
Detailed Summary
The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesFrance, Germany, Italy, Spain, Switzerland
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedDec 2010
Primary CompletionSep 2012
TodayJul 2026
First PostedDec 7, 2010
Enrollment StartNov 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.6 years ago
Interventions
iobitridoldrug
single IV injection
iopromidedrug
Single IV injection
iomeproldrug
Single IV injection