Safety and Efficacy of MultiHance in Pediatric Patients
Summary
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
Timeline
- Start
- 2006-04
- Primary completion
- 2008-09
- Completion
- 2008-09
Outcome
Met primary endpoint
Stopped: “Adequate statistical power at 92 dosed pts to meet study objectives.”
registry analysis (superiority or other test); Gadobenate Dimeglumine; p <0.0001; Mean Difference (Final Values) 1.3 (95% CI 1.1 to 1.5); t-test, 2 sided NCT00323310 ↗
registry analysis (superiority or other test); Gadobenate Dimeglumine; p <0.001; Mean Difference (Final Values) 1.3 (95% CI 1.1 to 1.6); t-test, 2 sided NCT00323310 ↗
registry analysis (superiority or other test); Gadobenate Dimeglumine; p <0.0001; Mean Difference (Final Values) 1.2 (95% CI 1.0 to 1.5); t-test, 2 sided NCT00323310 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gadobenate dimeglumine | Diagnostic / imaging agent | 0.1 mmol | Intravenous |