check_circleStudy Completed

Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases

Bayer Identifier:

91396

ClinicalTrials.gov Identifier:

NCT00652418

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

Both

Age

20 Years
  • - Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
  • - 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
July 2004 - October 2004
Phase
Phase 2
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hirosaki Daigaku Igakubu Fuzoku ByoinHirosaki-shi, 036-8563, Japan
Completed
Hamamatsu Ikadaigaku Igakubu Fuzoku ByoinHamamatsu-shi, 431-3192, Japan
Completed
Hamamatsu Ikadaigaku Igakubu Fuzoku ByoinHamamatsu-shi, 431-3192, Japan
Completed
Koritsu Nantan ByoinFunai-gun, 629-0197, Japan

Primary Outcome

  • Diagnostic ability
    date_rangeTime Frame:
    MRI image in blinded read
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Visibility
    date_rangeTime Frame:
    MRI image in blinded read
    enhanced_encryption
    Safety Issue:
    no
  • Diagnostic confidence
    date_rangeTime Frame:
    MRI image in blinded read
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.