Status:
TERMINATED
Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)
Lead Sponsor:
Chieko Hamada
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
The purpose of this study is to verify whether pitavastatin prevents from cardiovascular events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.
Detailed Description
It was already proved by the clinical trials that statins prevent from death and cardiovascular events. However, the efficacy of statins in patients with chronic hemodialysis has not been proved yet.
Eligibility Criteria
Inclusion
- patients under hemodialysis
- patients with hypercholesterolemia as defined by any of following parameters:
- LDL-C ≧ 100 mg / dL
- TC ≧ 180 mg / dL
- patients required cholesterol-lowering treatment by investigators.
- patients aged 20-75 years
- patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial
Exclusion
- patients taking statins or fibrates
- patients enrolled to the other trials using contraindication drugs of pitavastatin
- patients who had acute myocardial infarction within six months before the day of the agreement acquisition
- patients scheduled PCI and CABG within six months after the day of the agreement acquisition
- Patients who had diagnosis or doubt of malignant tumor
- patients corresponded to "Contraindications" of pitavastatin
- Familial hypercholesterolemia patients
- patients judged ineligible by investigators
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2014
Estimated Enrollment :
905 Patients enrolled
Trial Details
Trial ID
NCT00846118
Start Date
February 1 2009
End Date
September 30 2014
Last Update
August 30 2021
Active Locations (1)
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1
Division of Nephrology, Department of Internal Medicine, Juntendo Hospital
Tokyo, Japan, 113-8421