Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients

NCT00481364

Last updated date
Study Location
Ege University School of Medicine, Division of Nephrology
Bornova, Izmir, 35100, Turkey
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vascular Calcification, Atherosclerosis, Dyslipidemia, Inflammation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Vascular Calcification, Atherosclerosis, Dyslipidemia, InflammationAtorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
NCT00481364
  1. Bornova, Izmir
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Vascular Calcification
  • Atherosclerosis
  • Dyslipidemia
  • Inflammation
Intervention  ICMJE
  • Drug: atorvastatin
    atorvastatin 40 mg/day
  • Drug: placebo
    1 tb/day
Study Arms  ICMJE
  • Active Comparator: Statin
    Atorvastatin 40 mg/day
    Intervention: Drug: atorvastatin
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
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
 (submitted: May 30, 2007)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Ercan Ok, MDEge University, Division of Nephrology
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