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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

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 |
- Diagnostic ability [ Time Frame: MRI image in blinded read ]
- Visibility [ Time Frame: MRI image in blinded read ]
- Diagnostic confidence [ Time Frame: MRI image in blinded read ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Hirosaki-shi, Aomori, Japan, 036-8563 | |
Funai-gun, Kyoto, Japan, 629-0197 | |
Hamamatsu-shi, Shizuoka, Japan, 431-3192 |
Study Director: | Bayer Study Director | Bayer |
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 |
Magnevist Magnetic Resonance Angiography Meglumine gadopentetate Determination of effective dose in MRA |
Vascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Cardiovascular Diseases |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |