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

Bayer

Status and phase: Completed; Phase 2

Conditions: Peripheral Vascular Diseases; Magnetic Resonance Angiography; Peripheral Arterial Diseases

Treatments: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652418

91396

308612

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Arm 1

Active Comparator group

Treatment:

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

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

Arm 2

Experimental group

Treatment:

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

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