Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00652418
First received: April 1, 2008
Last updated: April 22, 2010
Last verified: April 2010
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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: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
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 |
|---|---|
| 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
|
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Bayer Schering Pharma AG, Therapeutic Area Head |
| ClinicalTrials.gov Identifier: | NCT00652418 History of Changes |
| Other Study ID Numbers: | 91396, 308612 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 22, 2010 |
| 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:
|
Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 16, 2013