drugset / Trial / NCT00558792

Coronary MDCTA With Iopamidol Injection 370

NCT00558792 ↗

Phase 2 Completed 210 enrolled Bracco Diagnostics, Inc
RandomizedParallel-groupTriple-blindDiagnostic

Summary

Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.

Timeline

Start
2007-11
Primary completion
2010-05
Completion
2010-05

Outcome

Mixed primary results

registry NUMBER Isovue 370, 70 mL: 949 Segments Visualized Accurately NCT00558792 ↗

registry analysis (superiority or other test); Isovue 370, 70 mL vs Isovue 370, 80 mL vs Isovue 370, 90 mL; p = 0.0099; Chi-squared NCT00558792 ↗

registry NUMBER Isovue 370, 70 mL: 925 Segments Visualized Accurately NCT00558792 ↗

registry analysis (superiority or other test); Isovue 370, 70 mL vs Isovue 370, 80 mL vs Isovue 370, 90 mL; p = 0.1212; Chi-squared NCT00558792 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Iopamidol Diagnostic / imaging agent 70 ml —
Subject Iopamidol Diagnostic / imaging agent 80 ml —
Subject Iopamidol Diagnostic / imaging agent 90 ml —

Indications