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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2004-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Magnetic Resonance Angiography Peripheral Vascular Diseases Peripheral Arterial Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Magnevist at a dose of 0.1 mmol/kg

Arm 2

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Magnevist at a dose of 0.2 mmol/kg

Interventions

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

Magnevist at a dose of 0.1 mmol/kg

Intervention Type DRUG

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

Magnevist at a dose of 0.2 mmol/kg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No