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

This study has been completed.

First Received on October 16, 2005. Last Updated on November 18, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240279

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 III

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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Dialysis

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240279

Locations

Netherlands
Research Site
Nieuwegein, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Crestor Medical Sciences Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00240279 History of Changes
Other Study ID Numbers:	4522IL/0096 Dutch SubStudy, D3562C00096
Study First Received:	October 16, 2005
Last Updated:	November 18, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

high blood cholesterol levels

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012