Status:
COMPLETED
The Effects of Lowering Low-density Lipoprotein Cholesterol Levels to New Targets on Cardiovascular Complications in Peritoneal Dialysis Patients
Lead Sponsor:
Clinical Research Center for End Stage Renal Disease, Korea
Collaborating Sponsors:
Ministry of Health & Welfare, Korea
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in dialysis patients. Although significant improvements have been made in the management of CVD in the general population, ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- End-stage renal disease patients treated with peritoneal dialysis for 3 or more months
- LDL cholesterol 100 mg/dl or higher within 3 months and total cholesterol level 220 mg/dl or higher
- Exclusion criteria:
- Hypersensitivity to statin, ezetimibe, fenofibrate
- Acute MI, angina, cerebrovascular accident, vascular intervention within the last 6 months
- Chronic obstructive pulmonary disease
- alanine transaminase \> 3 times the upper normal limit
- creatine kinase \> 3 times the upper normal limit
- Patients suffering form non-cardiac diseases with estimated survival less than 2 years
- Inevitable of cyclosporin, warfarin use
- Currently pregnant or breast feeding
- Any condition that might limit long-term compliance (e.g., psychiatric disorders)
- Participation in another clinical trial within 30 days prior to enrollment
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00999453
Start Date
October 1 2009
End Date
November 1 2015
Last Update
March 17 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Kyungpook National University Hospital, Daegu, South Korea
2
Severance Hospital
Seoul, South Korea