Magnevist (SH L 451A) Intra-Individual Dose Comparison Study in Magnetic Resonance Angiography - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00652418

Purpose

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.

Condition	Intervention	Phase
Magnetic Resonance Angiography Peripheral Vascular Diseases Peripheral Arterial Diseases	Drug: Magnevist (BAY86-4882, SH L 451A)	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Gadolinium DTPA

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Diagnostic ability [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visibility [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]
Diagnostic confidence [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	July 2004
Study Completion Date:	October 2004

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Magnevist (BAY86-4882, SH L 451A) Magnevist at a dose of 0.1 mmol/kg
Arm 2: Experimental	Drug: Magnevist (BAY86-4882, SH L 451A) Magnevist at a dose of 0.2 mmol/kg

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652418

Locations

Japan, Aomori

Hirosaki-shi, Aomori, Japan, 036-8563
Japan, Kyoto

Funai-gun, Kyoto, Japan, 629-0197
Japan, Shizuoka

Hamamatsu-shi, Shizuoka, Japan, 431-3192

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Therapeutic Area Head ( Bayer Schering Pharma AG )
Study ID Numbers:	91396, 308612
Study First Received:	April 1, 2008
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00652418 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:

Magnevist
Magnetic Resonance Angiography
Meglumine gadopentetate
Determination of effective dose in MRA

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010