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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447889
First Posted: March 15, 2007
Last Update Posted: November 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guerbet
March 14, 2007
March 15, 2007
November 26, 2008
March 2006
November 2007   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00447889 on ClinicalTrials.gov Archive Site
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A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)
This is a clinical study of gadoteric acid in non-coronary MR angiography.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arterial Occlusive Disease
Drug: gadoteric acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2007
November 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00447889
DGD-44-042
No
Not Provided
Not Provided
Not Provided
Guerbet
Not Provided
Study Chair: Corinne Dubourdieu, PhD Guerbet
Guerbet
November 2008

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