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Completed

NCT Number: NCT00652418

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

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.

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Key information

Conditions

Magnetic Resonance Angiography Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Arterial Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hirosaki-shi, Aomori, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Magnevist at a dose of 0.1 mmol/kg

Primary outcomes

  1. Diagnostic ability

    Time frame: MRI image in blinded read

Secondary outcomes

  1. Visibility

    Time frame: MRI image in blinded read

  2. Diagnostic confidence

    Time frame: MRI image in blinded read

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Apr 3, 2008
Registry last updated
Oct 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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