AURORA: Crestor 10mg vs Placebo in Subjects With ESRD - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240331

Purpose

The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.

Condition	Intervention	Phase
End Stage Renal Failure	Drug: 10mg Rosuvastatin	Phase III

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-Group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-Stage Renal Failure on Chronic Haemodialysis Treatment

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assessment of time to major cardiovascular event (combined endpoint of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death).

Secondary Outcome Measures:

To assess the safety of treatment
To determine the cost due to hospitalisations (expressed as cost per life year saved)
To determine the effect of treatment on the % changes in various cholesterol laboratory assessments

Estimated Enrollment:	2700
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months

Exclusion Criteria:

Subjects will have no underlying condition that is expected to limit survival to less than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should not have received a statin therapy within the past 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240331

Show 241 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Crestor Medical Sciences Director, MD

AstraZeneca

More Information

Study ID Numbers:	4522IL/0096 (D3562C00096)
Study First Received:	October 16, 2005
Last Updated:	October 5, 2006
ClinicalTrials.gov Identifier:	NCT00240331
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Renal Insufficiency
Rosuvastatin
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009