check_circleStudy Completed
Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases
Bayer Identifier:
91396
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Magnevist (SH L 451A) intra-individual dose comparison study in Magnetic Resonance Angiography
Trial 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.
Key Participants Requirements
Sex
BothAge
20 YearsTrial summary
Enrollment Goal
12Trial Dates
July 2004 - October 2004Phase
Phase 2Could I Receive a placebo
NoProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hirosaki Daigaku Igakubu Fuzoku Byoin | Hirosaki-shi, 036-8563, Japan |
Completed | Hamamatsu Ikadaigaku Igakubu Fuzoku Byoin | Hamamatsu-shi, 431-3192, Japan |
Completed | Hamamatsu Ikadaigaku Igakubu Fuzoku Byoin | Hamamatsu-shi, 431-3192, Japan |
Completed | Koritsu Nantan Byoin | Funai-gun, 629-0197, Japan |
Primary Outcome
- Diagnostic abilitydate_rangeTime Frame:MRI image in blinded readenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Visibilitydate_rangeTime Frame:MRI image in blinded readenhanced_encryptionnoSafety Issue:
- Diagnostic confidencedate_rangeTime Frame:MRI image in blinded readenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2