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

Peripheral Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652418
• Other study ID #: 91396
• Secondary ID: 308612
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2008
• Last updated: October 10, 2013
• Start date: July 2004
• Est. completion date: October 2004

Study information

• Verified date: October 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Drug:
• Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Magnevist at a dose of 0.1 mmol/kg
• Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Magnevist at a dose of 0.2 mmol/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic ability		MRI image in blinded read	No
Secondary	Visibility		MRI image in blinded read	No
Secondary	Diagnostic confidence		MRI image in blinded read	No

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