A multicentre, randomised, double-blind, parallel group, phase IV study to compare the renal effects of the non-ionic iso-osmolar contrast medium iodixanol 320 mgI/mL Visipaque with the non-ionic low osmolar contrast medium iopamidol 370 mgI/mL in subjects with impaired renal function and diabetes mellitus undergoing coronary angiography with or without percutaneous coronary intervention PCI .
Phase 1
- Conditions
- coronary angiography with or without percutaneous coronary intervention PCI .MedDRA version: 9.1Level: LLTClassification code 10011078Term: Coronary artery disease
- Registration Number
- EUCTR2004-005002-68-IT
- Lead Sponsor
- AMERSHAM HEALTH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method