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Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT

This study is not yet open for participant recruitment.
Verified July 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jung-Eun Cheon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01654354
First received: July 20, 2012
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT


Condition Intervention Phase
Abdominal CT
 Drug: NEOVIST 370 INJ.(Iopromide 768.86mg)
Drug: Ultravist 370 INJ.(Iopromide 768.86mg)
 Phase 4

Study Type: Interventional
Official Title: Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT

Resource links provided by NLM:

Drug Information available for: Iopromide
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Aged 20 to 75 years old.
  • Subjects who need CT scan
  • Subjects who are willing to participate in the study and to write the informed consent form.

Exclusion Criteria:

  • Subjects with severe hepatopathy whose AST or ALT ≥ 1,000 IU/L, Subjects with liver cirrhosis whose AST or ALT ≥ UNL(upper normal limit) X 3
  • Severe disorder of thyroid gland
  • homocystinuria
  • pregnant or breastfeeding female subjects, or female subjects with childbearing potential who are not willing to use proper contraception methods
  • Participation in another clinical trial within 30days of enrollment into this study.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jung-Eun Cheon, Associate Professor in Radiology(Pediatric Radiology), Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01654354     History of Changes
Other Study ID Numbers: Neovist IIT
Study First Received: July 20, 2012
Last Updated: July 30, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)

ClinicalTrials.gov processed this record on May 23, 2013