Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatment pitavastatin
Sponsor Chieko Hamada
Start date February 2009
End date July 2014
Trial size 1550 participants
Trial identifier NCT00846118, 208-032

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Pitavastatin in addition to optimal standard care
pitavastatin LIVALO
1-4mg/day
(No Intervention)

Primary Outcomes

Measure
all cause mortality
time frame: whole observational period
Myocardial infarction of the new onset
time frame: whole observational period

Secondary Outcomes

Measure
Cardiac death
time frame: whole observational period
Myocardial infarction of the new onset
time frame: whole observational period

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.
Principal investigator Yasuhiko Tomino, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Juntendo University Hospital.