Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention Phase
Arterial Occlusive Disease
Drug: gadoteric acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)

Further study details as provided by Guerbet:

Study Start Date: March 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447889

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Guerbet
Investigators
Study Chair: Corinne Dubourdieu, PhD Guerbet
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447889     History of Changes
Other Study ID Numbers: DGD-44-042
Study First Received: March 14, 2007
Last Updated: November 25, 2008
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014