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

NCT ID: NCT01654354

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Conditions

Abdominal CT

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

NEOVIST 370 INJ.(Iopromide 768.86mg)

Intervention Type: DRUG

Ultravist 370 INJ.(Iopromide 768.86mg)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jung-Eun Cheon

Associate Professor in Radiology(Pediatric Radiology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Neovist IIT

Identifier Type: -

Identifier Source: org_study_id