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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240279
First Posted: October 18, 2005
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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)

Condition Intervention Phase
Hypercholesterolemia Drug: Rosuvastatin Procedure: aortic pulse wave velocity measurements Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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).

Estimated Enrollment: 10
Study Start Date: January 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240279


Locations
Netherlands
Research Site
Nieuwegein, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Crestor Medical Sciences Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00240279     History of Changes
Other Study ID Numbers: 4522IL/0096 Dutch SubStudy
D3562C00096
First Submitted: October 16, 2005
First Posted: October 18, 2005
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
high blood cholesterol levels

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors