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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00240331 |
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 |
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 |
Estimated Enrollment: | 2700 |
Study Start Date: | July 2004 |
Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Crestor Medical Sciences Director, MD | AstraZeneca |
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 |
Renal Insufficiency Rosuvastatin Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |