Trial Condition(s):

Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases

Magnevist (SH L 451A) intra-individual dose comparison study in Magnetic Resonance Angiography

Bayer Identifier:

91396

ClinicalTrials.gov Identifier:

NCT00652418

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hirosaki Daigaku Igakubu Fuzoku Byoin

Hirosaki-shi, Japan, 036-8563

Status
Completed
 
Locations

Hamamatsu Ikadaigaku Igakubu Fuzoku Byoin

Hamamatsu-shi, Japan, 431-3192

Status
Completed
 
Locations

Koritsu Nantan Byoin

Funai-gun, Japan, 629-0197

Status
Completed
 

Trial Design