Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
NCT00481364
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- aged between 18 and 80 years
- on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- willingness to participate to the study with a written informed consent
- to have serious life-limiting co-morbid situations, namely active malignancy, active
infection, end-stage cardiac, pulmonary, or hepatic disease
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients | |||
Official Title ICMJE | Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study | |||
Brief Summary | This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation. | |||
Detailed Description | The effects of statin treatment on coronary artery calcifications, carotid artery intima-media thickness, and endothelial functions have never been investigated in hemodialysis patients. Regarding inflammation, the present data in hemodialysis patients are derived from small studies with short follow-up. 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 446 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Turkey | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00481364 | |||
Other Study ID Numbers ICMJE | 06-4.1/2 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Ercan OK, Ege University | |||
Study Sponsor ICMJE | Ercan OK | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Ege University | |||
Verification Date | September 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |