NCT00185276

Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

Randomized, Multi-center Open Label Study of the Safety (Open-label) and Efficacy (Open-label & Blinded Reader) of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) at Two Dose Levels and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients Undergoing MRA of the Infrarenal Aorta and Peripheral Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as Standard of Reference

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

Detailed description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DRUG	Gadopentetate dimeglumine (Magnevist, BAY86-4882)	Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight
DRUG	Gadopentetate dimeglumine (Magnevist, BAY86-4882)	Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight

Timeline

• Start date: 2003-03-01
• Completion: 2004-08-01
• First posted: 2005-09-16
• Last updated: 2014-12-30