GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

NCT ID: NCT01095081

Last Updated: 2015-01-21

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

Total Enrollment

23775 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-04-30

Brief Summary

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Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients

Detailed Description

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Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.

Conditions

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Magnetic Resonance Imaging Magnetic Resonance Angiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Gadobutrol (Gadovist, BAY86-4875)

Intervention Type DRUG

Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.

Interventions

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Gadobutrol (Gadovist, BAY86-4875)

Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
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

Locations

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Many Locations, , Bosnia and Herzegovina

Site Status

Many Locations, , Canada

Site Status

Many Locations, , China

Site Status

Many Locations, , Czechia

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Many Locations, , France

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Greece

Site Status

Many Locations, , Hong Kong

Site Status

Many Locations, , Hungary

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Kazakhstan

Site Status

Many Locations, , Kyrgyzstan

Site Status

Many Locations, , Poland

Site Status

Many Locations, , Russia

Site Status

Many Locations, , South Africa

Site Status

Many Locations, , South Korea

Site Status

Many Locations, , Spain

Site Status

Many Locations, , Taiwan

Site Status

Many Locations, , Thailand

Site Status

Many Locations, , Vietnam

Site Status

Countries

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Bosnia and Herzegovina Canada China Czechia France Germany Greece Hong Kong Hungary Italy Kazakhstan Kyrgyzstan Poland Russia South Africa South Korea Spain Taiwan Thailand Vietnam

Other Identifiers

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GV0901

Identifier Type: OTHER

Identifier Source: secondary_id

14823

Identifier Type: -

Identifier Source: org_study_id

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