Back to resultsThe Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Rosuvastatin
aortic pulse wave velocity measurements
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring high blood cholesterol levels
Eligibility Criteria
Inclusion Criteria: Signed informed consent, between 50 and 80 years of age, end stage renal failure patients receiving hemodialysis Exclusion Criteria: Received statins within past 6 months, a clear indication for use of lipid altering drug, contra indication for lipid altering drug, history of statin induced myopathy items in very
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
Secondary Outcome Measures
To investigate the effect of rosuvastatin compared to placebo on the aortic pressure wave in hemodialysis patients (at 3 months/ 6 months and 12 months).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00240279
Brief Title
The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
Official Title
The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
high blood cholesterol levels
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Procedure
Intervention Name(s)
aortic pulse wave velocity measurements
Primary Outcome Measure Information:
Title
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
Secondary Outcome Measure Information:
Title
To investigate the effect of rosuvastatin compared to placebo on the aortic pressure wave in hemodialysis patients (at 3 months/ 6 months and 12 months).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent, between 50 and 80 years of age, end stage renal failure patients receiving hemodialysis
Exclusion Criteria:
Received statins within past 6 months, a clear indication for use of lipid altering drug, contra indication for lipid altering drug, history of statin induced myopathy items in very
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Crestor Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Nieuwegein
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
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