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Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

NCT ID: NCT00185276

Last Updated: 2014-12-30

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

PHASE3

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-08-31

Brief Summary

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The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

Detailed Description

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This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Conditions

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Peripheral Vascular Disease

Keywords

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Structural abnormalities of the infrarenal aorta and peripheral arteries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight

Arm 2

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight

Interventions

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Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight

Intervention Type DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has known or suspected peripheral vascular disease
* Is scheduled for X-ray angiography

Exclusion Criteria

* Has any contraindication to magnetic resonance imaging
* Is scheduled for any procedure before the X-ray angiography
* Had previously had stents placed bilaterally in the region to be imaged
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Countries

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Denmark Estonia

Other Identifiers

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306781

Identifier Type: -

Identifier Source: secondary_id

91208

Identifier Type: -

Identifier Source: org_study_id