Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities

NCT00652418 Phase 2 COMPLETED

The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.

Details

Lead sponsor	Bayer
Phase	Phase 2
Status	COMPLETED
Enrolment	12
Start date	2004-07
Completion	2004-10

Conditions

• Magnetic Resonance Angiography
• Peripheral Vascular Diseases
• Peripheral Arterial Diseases

Interventions

• Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
• Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Primary outcomes

• Diagnostic ability — MRI image in blinded read

Countries

Japan