CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,776 enrolled
Drug / intervention
10mg Rosuvastatin +1 moredrug
Likely dose
Rosuvastatin 10 mgAI-extracted
Key inclusion· 2
  • ✓Age 50–80 years
  • ✓End-stage renal failure on chronic hemodialysis for at least 3 months
Key exclusion· 2
  • ✕Underlying condition expected to limit survival to less than 1 year, unrelated to ESRD
  • ✕Statin therapy within the past 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00240331
NCT00240331Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Oct 18, 2005·Updated May 19, 2011

In Brief

A Phase 3 clinical trial evaluating 10mg Rosuvastatin and Placebo for Renal Failure. Completed, enrolled 2,776 participants across 239 sites in 25 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure
CountriesAustralia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Mexico, Netherlands, Norway, Poland, South Korea, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2005
Enrollment StartJan 1, 2003
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.7 years ago

Interventions

10mg Rosuvastatindrug

Placebodrug