The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study

Hypercholesterolemia Clinical Trial

Official title:

The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240279
• Other study ID #: 4522IL/0096 Dutch SubStudy
• Secondary ID: D3562C00096
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2005
• Last updated: November 18, 2010
• Start date: January 2003
• Est. completion date: October 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

Procedure:
• aortic pulse wave velocity measurements

Locations

Country	Name	City	State
Netherlands	Research Site	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).