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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652418
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Magnetic Resonance Angiography Peripheral Vascular Diseases Peripheral Arterial Diseases Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : July 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

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


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic ability [ Time Frame: MRI image in blinded read ]

Secondary Outcome Measures :
  1. Visibility [ Time Frame: MRI image in blinded read ]
  2. Diagnostic confidence [ Time Frame: MRI image in blinded read ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652418


Locations
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Japan
Hirosaki-shi, Aomori, Japan, 036-8563
Funai-gun, Kyoto, Japan, 629-0197
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00652418    
Other Study ID Numbers: 91396
308612
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013
Keywords provided by Bayer:
Magnevist
Magnetic Resonance Angiography
Meglumine gadopentetate
Determination of effective dose in MRA
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases