NCT01260636

Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries

A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries

Conditions

• Carotid, Aortic, Renal or Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Gadobenate Dimeglumine	0.1 mmol/kg, single dose
DRUG	Gadopentetate Dimeglumine	Double dose of 0.2 mmol/kg

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-12-15
• Last updated: 2012-01-05

Locations

1 site across 1 country: China