Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography

Exclusion Criteria:

• Patients with an ankle brachial pressure index (ABPI) of 0.3 or less

• Patients with allergy to contrast media

• Patients with serious hepatic impairment

• Patients with serious renal impairment