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

This study has been completed.

First Received: October 16, 2005 Last Updated: March 13, 2009 History of Changes

Sponsored by:	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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Dialysis Kidney Failure

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study

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:	October 2003
Study Completion Date:	October 2008

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

Study ID Numbers:	4522IL/0096, Dutch Substudy
Study First Received:	October 16, 2005
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00240279 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

high blood cholesterol levels

Study placed in the following topic categories:

Antimetabolites
Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Antilipemic Agents
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009