Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
NCT ID: NCT00481364
Last Updated: 2013-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2006-11-30
2008-12-31
Brief Summary
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Detailed Description
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We postulate that atorvastatin would reduce progression of coronary calcification and carotid artery intima-media thickness, decrease inflammation, and improve endothelial function.
In this prospective, controlled, randomized study, four hundred forty-six prevalent hemodialysis patients who meet inclusion and exclusion criteria will be randomized to atorvastatin (20 mg/day in first month; increased to 40 mg/day afterwards) and placebo arms (each arm consists of 223 patients), after completion of baseline investigations. Randomization will be performed with random permuted blocks and will be stratified according to dialysis center, age, sex, diabetic status, duration of dialysis, high flux dialyser use, and dialysate calcium level. Follow-up period will be twelve months.
It is estimated that 446 patients would provide 90% power with a two-sided, alpha error rate of 5%, of detecting a significant difference between treatment arms. Dropout rate is expected to be 20%, not to be replaced.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Statin
Atorvastatin 40 mg/day
atorvastatin
atorvastatin 40 mg/day
Placebo
placebo
placebo
1 tb/day
Interventions
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atorvastatin
atorvastatin 40 mg/day
placebo
1 tb/day
Eligibility Criteria
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Inclusion Criteria
* on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
* willingness to participate to the study with a written informed consent
Exclusion Criteria
* to be scheduled for living donor renal transplantation
* pregnancy or lactating
* history of coronary bypass grafting, acute myocardial infarction or unstable angina pectoris confirmed by angiography within three months of randomization
* presence of an absolute indication to use lipid lowering drug or an absolute contraindication for lipid lowering therapy according to investigator's opinion
* history of statin sensitivity or adverse reaction to statins
* receiving any lipid-lowering agents within three months of randomization
* uncontrolled hypothyroidism defined as TSH level higher than 1.5 times of upper limit
* receipt of any investigational drug within 30 days before randomization
* inability to tolerate oral medication or history of significant malabsorption
* treatment with steroids or immunosuppressive drugs
* alcohol abuse, drug abuse
* ALT and/or AST levels more than three times above the upper limit of normal or symptomatic hepatobiliary disease
* unexplained CK \> 3 times the upper limit of the normal range
* inability to give informed consent because of mental incompetence or a psychiatric disorder
18 Years
80 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Ercan OK
OTHER
Responsible Party
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Ercan OK
professor
Principal Investigators
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Ercan Ok, MD
Role: PRINCIPAL_INVESTIGATOR
Ege University, Division of Nephrology
Locations
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Ege University School of Medicine, Division of Nephrology
Bornova, İzmir, Turkey (Türkiye)
Countries
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Other Identifiers
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06-4.1/2
Identifier Type: -
Identifier Source: org_study_id