AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
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
2 other identifiers
interventional
2,776
24 countries
237
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2003
Longer than P75 for phase_3
237 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 16, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
November 4, 2009
CompletedMay 19, 2011
May 1, 2011
5.8 years
October 16, 2005
September 29, 2009
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary Outcomes (7)
Number of Randomised Participants That Died From Any Cause.
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Cardiovascular Cause
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Non Cardiovascular Cause
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
- +2 more secondary outcomes
Study Arms (2)
Rosuvastatin 10mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORmatching Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (239)
Research Site
St Leonards, New South Wales, Australia
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Herston, Queensland, Australia
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Bregenz, Austria
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Feldkirch-Tisis, Austria
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Graz, Austria
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Innsbruck, Austria
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Linz, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Wels, Austria
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Aalst, Belgium
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Antwerp, Belgium
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Brussels, Belgium
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La Louvière, Belgium
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Leuven, Belgium
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Liège, Belgium
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Curitiba, Paraná, Brazil
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São Paulo, São Paulo, Brazil
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Lethbridge, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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York, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Kitchener, Canada
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Rosemount, Canada
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Hodonín, Czechia
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Hradec Králové, Czechia
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Liberec, Czechia
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Pardubice, Czechia
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Prague, Czechia
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Tábor, Czechia
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Ústí nad Labem, Czechia
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Fredericia, Denmark
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Frederiksberg, Denmark
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Herlev, Denmark
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Holbæk, Denmark
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Horsens, Denmark
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København Ø, Denmark
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Roskilde, Denmark
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Rønne, Denmark
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Slagelse, Denmark
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Sønderborg, Denmark
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Viborg, Denmark
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Ekenäs, Finland
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Helsinki, Finland
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Hyvinkää, Finland
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Joensuu, Finland
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Kotka, Finland
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Kuopio, Finland
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Lahti, Finland
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Oulu, Finland
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Pori, Finland
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Tampere, Finland
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Turku, Finland
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Amiens, France
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Annonay, France
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Aubervilliers, France
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Beauvais, France
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Béthune, France
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Boulogne-sur-Mer, France
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Chambéry, France
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Champigny-sur-Marne, France
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Colmar, France
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Creil, France
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Évreux, France
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Fleury-Mérogis, France
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Foix, France
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Le Kremlin-Bicêtre, France
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Maubeuge, France
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Meaux, France
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Mont-de-Marsan, France
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Montbonnot-Saint-Martin, France
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Nîmes, France
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Olivet, France
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Paris, France
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Quimper, France
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Saint-Maurice, France
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Saint-Michel, France
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Tournan-en-Brie, France
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Valenciennes, France
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Vandœuvre-lès-Nancy, France
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Vichy, France
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Ansbach, Germany
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Aschaffenburg, Germany
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Bad Münder am Deister, Germany
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Berlin, Germany
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Bischofswerda, Germany
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Dresden, Germany
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Duisburg, Germany
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Düsseldorf, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Greifswald, Germany
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Hannoversch Münden, Germany
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Ingolstadt, Germany
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Jena, Germany
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Kaufbeuren, Germany
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Lüdenscheid, Germany
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Marktheidenfeld, Germany
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München, Germany
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Pfarrkirchen, Germany
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Pirmasens, Germany
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Regensburg, Germany
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Rostock, Germany
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Saarbrücken, Germany
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Tangermünde, Germany
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Waldshut, Germany
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Alexandroupoli, Greece
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Athens, Greece
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Ioannina, Greece
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Thessaloniki, Greece
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Véroia, Greece
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Budapest, Hungary
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Győr, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Szeged, Hungary
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Székesfehérvár, Hungary
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Veszprém, Hungary
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Reykjavik, Iceland
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Galway, Ireland
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Bergamo, BG, Italy
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Treviglio, BG, Italy
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Cremona, CR, Italy
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Genova, GE, Italy
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Lodi, LO, Italy
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Milan, Mi, Italy
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Rozzano, MI, Italy
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Reggio Calabria, RC, Italy
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Busto Arsizio, VA, Italy
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México, D.f., Mexico
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Acapulco de Juárez, Guerrero, Mexico
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Guadalajara, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Distrito Federal, Mexico
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San Luis Potosí City, Mexico
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's-Hertogenbosch, Netherlands
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Alkmaar, Netherlands
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Almelo, Netherlands
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Deventer, Netherlands
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Dordrecht, Netherlands
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Emmen, Netherlands
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Groningen, Netherlands
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Leeuwarden, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Sittard, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Bergen, Norway
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Drammen, Norway
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Fredrikstad, Norway
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Lillehammer, Norway
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Lorenskog, Norway
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Oslo, Norway
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Skien, Norway
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Stavanger, Norway
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Trondheim, Norway
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Tønsberg, Norway
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Bialystok, Poland
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Opole, Poland
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Płock, Poland
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Rybnik, Poland
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Włocławek, Poland
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Seongnam-si, Korea, South Korea
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Seoul, Korea, South Korea
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Eksjö, Sweden
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Eskilstuna, Sweden
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Falun, Sweden
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Gävle, Sweden
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Gothenburg, Sweden
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Jönköping, Sweden
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Karlstad, Sweden
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Linköping, Sweden
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Lund, Sweden
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Mölndal, Sweden
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Norrköping, Sweden
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Örebro, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Trollhättan, Sweden
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Uppsala, Sweden
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Aarau, Switzerland
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Bern, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Istanbul, Altunizade, Turkey (Türkiye)
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Cebeci, Ankara, Turkey (Türkiye)
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Kampus, Antalya, Turkey (Türkiye)
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Antalya, Arapsuyu, Turkey (Türkiye)
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Ankara, Besevler, Turkey (Türkiye)
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Izmir, Bornova, Turkey (Türkiye)
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Bursa, Gorukle, Turkey (Türkiye)
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Istanbul, Haydarpasa, Turkey (Türkiye)
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Antrim, Northern Ireland, United Kingdom
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Belfast, Northern Ireland, United Kingdom
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Newry, Northern Ireland, United Kingdom
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Omagh, Northern Ireland, United Kingdom
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Bradford, United Kingdom
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Dumfries, United Kingdom
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Dundee, United Kingdom
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Glasgow, United Kingdom
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Hull, United Kingdom
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Kilmarnock, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Newcastle, United Kingdom
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Plymouth, United Kingdom
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Rhyl, United Kingdom
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Sheffield, United Kingdom
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Surrey, United Kingdom
Related Publications (1)
Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.
PMID: 19332456DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The endpoints were originally intended to be time to event endpoints, however we are unable to report the data as intended due to the nature of time to event endpoints. Therefore we have reported the number of participants who reached the event.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Crestor Medical Sciences Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2005
First Posted
October 18, 2005
Study Start
January 1, 2003
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 19, 2011
Results First Posted
November 4, 2009
Record last verified: 2011-05