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Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries

NCT ID: NCT00310557

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

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2004-12-31

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 renal 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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Renal Artery Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist)

Intervention Type DRUG

Approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Interventions

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Gadopentetate dimeglumine (Magnevist)

Approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Has known or suspected renal artery 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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United States

Other Identifiers

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304629

Identifier Type: -

Identifier Source: secondary_id

90940

Identifier Type: -

Identifier Source: org_study_id