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Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

NCT00652418 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Magnetic Resonance Angiography
  • Peripheral Vascular Diseases
  • Peripheral Arterial Diseases

Interventions

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Magnevist at a dose of 0.1 mmol/kg

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Magnevist at a dose of 0.2 mmol/kg

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2004-10-31
Completion
2004-10-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652418 on ClinicalTrials.gov