AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)

NCT ID: NCT00240331

Last Updated: 2011-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Rosuvastatin 10mg

Group Type EXPERIMENTAL

10mg Rosuvastatin

Intervention Type DRUG

Placebo

matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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10mg Rosuvastatin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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AstraZeneca Crestor Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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Australia 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

References

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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.

Reference Type DERIVED
PMID: 19332456 (View on PubMed)

Other Identifiers

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D3562C00096

Identifier Type: -

Identifier Source: secondary_id

4522IL/0096

Identifier Type: -

Identifier Source: org_study_id

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