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| ID | Type | Description | Link |
|---|---|---|---|
| 308612 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) | Drug | Magnevist at a dose of 0.1 mmol/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic ability | MRI image in blinded read |
| Measure | Description | Time Frame |
|---|---|---|
| Visibility | MRI image in blinded read | |
| Diagnostic confidence | MRI image in blinded read |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirosaki-shi | Aomori | 036-8563 | Japan | |||
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| Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) | Drug | Magnevist at a dose of 0.2 mmol/kg |
|
| Funai-gun |
| Kyoto |
| 629-0197 |
| Japan |
| Hamamatsu | Shizuoka | 431-3192 | Japan |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
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