A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography

This study has been completed.

Sponsor:

Information provided by:

Guerbet

ClinicalTrials.gov Identifier:

NCT00447889

First received: March 14, 2007

Last updated: November 25, 2008

Last verified: November 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 14, 2007

Last Updated Date

November 25, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00447889 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography

Official Title ^ICMJE

A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)

Brief Summary

This is a clinical study of gadoteric acid in non-coronary MR angiography.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Arterial Occlusive Disease

Intervention ^ICMJE

Drug: gadoteric acid

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, at least the age of legal maturity
Strongly suspected of having non-coronary arterial disease, detected clinically
Scheduled to undergo x-ray angiography examination
Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
Females of childbearing potential must have a documented negative urine pregnancy test.

Exclusion Criteria:

Contraindication to magnetic resonance imaging (MRI)
Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
Congenital morphologic vascular abnormalities
Known allergy to gadolinium chelates
Pregnant, breast feeding, or planning to become pregnant during the trial
Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00447889

Other Study ID Numbers ^ICMJE

DGD-44-042

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Guerbet

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Corinne Dubourdieu, PhD

Guerbet

Information Provided By

Guerbet

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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