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Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease (PLANET II)

14. Juni 2011 aktualisiert von: AstraZeneca

Randomised, Double-blind, 52-wk, Parallel-grp Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Non-diabetic Patients With Moderate Proteinuria

The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

237

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Brasilien
    • PR
      • Curitiba, PR, Brasilien
        • Research Site
    • SP
      • Sao Paulo, SP, Brasilien
        • Research Site
  • Bulgarien
      • Blagoevgrad, Bulgarien
        • Research Site
      • Burgas, Bulgarien
        • Research Site
      • Gabrovo, Bulgarien
        • Research Site
      • Pleven, Bulgarien
        • Research Site
      • Plovdiv, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
      • Varna, Bulgarien
        • Research Site
      • Veliko Turnovo, Bulgarien
        • Research Site
  • Deutschland
      • Berlin, Deutschland
        • Research Site
      • Cloppenburg, Deutschland
        • Research Site
      • Demmin, Deutschland
        • Research Site
      • Dusseldorf, Deutschland
        • Research Site
      • Elsenfeld, Deutschland
        • Research Site
      • Gottingen, Deutschland
        • Research Site
      • Hannover, Deutschland
        • Research Site
      • Wurzburg, Deutschland
        • Research Site
  • Dänemark
      • Fredericia, Dänemark
        • Research Site
      • Herlev, Dänemark
        • Research Site
      • Holbaek, Dänemark
        • Research Site
      • Kobenhavn, Dänemark
        • Research Site
      • Roskilde, Dänemark
        • Research Site
      • Viborg, Dänemark
        • Research Site
  • Italien
    • BG
      • Bergamo, BG, Italien
        • Research Site
    • BO
      • Bologna, BO, Italien
        • Research Site
    • BS
      • Brescia, BS, Italien
        • Research Site
    • CT
      • Acireale, CT, Italien
        • Research Site
    • FG
      • Foggia, FG, Italien
        • Research Site
    • FI
      • Firenze, FI, Italien
        • Research Site
    • PR
      • Parma, PR, Italien
        • Research Site
    • RC
      • Reggio Calabria, RC, Italien
        • Research Site
    • SS
      • Sassari, SS, Italien
        • Research Site
    • TE
      • Teramo, TE, Italien
        • Research Site
    • TO
      • Torino, TO, Italien
        • Research Site
    • TV
      • Castelfranco Veneto, TV, Italien
        • Research Site
      • Treviso, TV, Italien
        • Research Site
    • VE
      • Mestre, VE, Italien
        • Research Site
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • Research Site
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Kanada
        • Research Site
    • Ontario
      • Courtice, Ontario, Kanada
        • Research Site
      • East York, Ontario, Kanada
        • Research Site
      • Oakville, Ontario, Kanada
        • Research Site
      • Oshawa, Ontario, Kanada
        • Research Site
      • Richmond Hill, Ontario, Kanada
        • Research Site
      • Scarborough, Ontario, Kanada
        • Research Site
      • Thunder Bay, Ontario, Kanada
        • Research Site
      • Toronto, Ontario, Kanada
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Kanada
        • Research Site
      • Montreal, Quebec, Kanada
        • Research Site
  • Mexiko
      • Aguascalientes, Mexiko
        • Research Site
      • D.F, Mexiko
        • Research Site
      • Durango, Mexiko
        • Research Site
      • San Luis Potos�, Mexiko
        • Research Site
    • DF
      • Mexico, DF, Mexiko
        • Research Site
    • Jalisco
      • Zapopan, Jalisco, Mexiko
        • Research Site
    • Morelos
      • Cuernavaca, Morelos, Mexiko
        • Research Site
  • Rumänien
      • Brasov, Rumänien
        • Research Site
      • Bucuresti, Rumänien
        • Research Site
      • Constanta, Rumänien
        • Research Site
      • Craiova, Rumänien
        • Research Site
      • Iasi, Rumänien
        • Research Site
      • Suceava, Rumänien
        • Research Site
    • Cluj
      • Cluj Napoca, Cluj, Rumänien
        • Research Site
    • Timis
      • Timisoara, Timis, Rumänien
        • Research Site
  • Südafrika
      • Cape Town, Südafrika
        • Research Site
      • Durban, Südafrika
        • Research Site
      • Pretoria, Südafrika
        • Research Site
    • Gauteng
      • Johannesburg, Gauteng, Südafrika
        • Research Site
    • W Cape
      • Parow, W Cape, Südafrika
        • Research Site
  • Ungarn
      • Ajka, Ungarn
        • Research Site
      • Baja, Ungarn
        • Research Site
      • Balatonfured, Ungarn
        • Research Site
      • Budapest, Ungarn
        • Research Site
      • Debrecen, Ungarn
        • Research Site
      • Eger, Ungarn
        • Research Site
      • Gyula, Ungarn
        • Research Site
      • Gy�r, Ungarn
        • Research Site
      • Keszthely, Ungarn
        • Research Site
      • Miskolc, Ungarn
        • Research Site
      • Nyiregyhaza, Ungarn
        • Research Site
      • Szolnok, Ungarn
        • Research Site
      • Szombathely, Ungarn
        • Research Site
      • Zalaegerszeg, Ungarn
        • Research Site
  • Vereinigte Staaten
    • Arizona
      • Avondale, Arizona, Vereinigte Staaten
        • Research Site
      • Phoenix, Arizona, Vereinigte Staaten
        • Research Site
    • California
      • Pasadena, California, Vereinigte Staaten
        • Research Site
      • Riverside, California, Vereinigte Staaten
        • Research Site
    • Florida
      • Clearwater, Florida, Vereinigte Staaten
        • Research Site
      • Hollywood, Florida, Vereinigte Staaten
        • Research Site
      • Jacksonville, Florida, Vereinigte Staaten
        • Research Site
    • Georgia
      • Augusta, Georgia, Vereinigte Staaten
        • Research Site
    • Kansas
      • Topeka, Kansas, Vereinigte Staaten
        • Research Site
    • Maryland
      • Columbia, Maryland, Vereinigte Staaten
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, Vereinigte Staaten
        • Research Site
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten
        • Research Site
    • Missouri
      • Columbia, Missouri, Vereinigte Staaten
        • Research Site
    • New York
      • Orchard Park, New York, Vereinigte Staaten
        • Research Site
    • North Carolina
      • Winston Salem, North Carolina, Vereinigte Staaten
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten
        • Research Site
    • South Carolina
      • Columbia, South Carolina, Vereinigte Staaten
        • Research Site
    • Texas
      • Houston, Texas, Vereinigte Staaten
        • Research Site
      • San Antonio, Texas, Vereinigte Staaten
        • Research Site
    • Virginia
      • Richmond, Virginia, Vereinigte Staaten
        • Research Site
    • Washington
      • Gig Harbor, Washington, Vereinigte Staaten
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Vereinigte Staaten
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • greater than or equal to 18 years of age
  • Hyperlipidemia
  • Urinary protein

Exclusion Criteria:

  • Previous rosuvastatin treatment < 6 months prior to Visit 1
  • Statin intolerance
  • Severe hypertension
  • Diabetes

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Urinary Protein/Creatinine Ratio at Week 52 [LOCF]
Zeitfenster: Assessed at baseline and Week 52 (LOCF)
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Assessed at baseline and Week 52 (LOCF)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Urinary Protein/Creatinine Ratio at Week 26.
Zeitfenster: Assessed at baseline and Week 26
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Assessed at baseline and Week 26
Urinary Albumin/Creatinine Ratio at Week 26
Zeitfenster: Assessed at baseline and Week 26
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
Assessed at baseline and Week 26
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Zeitfenster: Assessed at baseline and Week 52 [LOCF]
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
Assessed at baseline and Week 52 [LOCF]
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
Zeitfenster: Assessed at baseline and Week 26
The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.
Assessed at baseline and Week 26
Change From Baseline in eGFR at Week 52 [LOCF]
Zeitfenster: Assessed at baseline and Week 52 [LOCF]
The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.
Assessed at baseline and Week 52 [LOCF]
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.
Zeitfenster: baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.
Zeitfenster: 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C
Zeitfenster: 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26
Zeitfenster: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26
Zeitfenster: Baseline and 26 weeks

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.

)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
Zeitfenster: 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
52 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Zeitfenster: Baseline and 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 26 weeks
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Zeitfenster: Baseline and 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
Baseline and 52 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Ermittler

  • Studienleiter: AstraZeneca Crestor Medical Science Director, MD, AstraZeneca

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2006

Primärer Abschluss (Tatsächlich)

1. Juni 2009

Studienabschluss (Tatsächlich)

1. Juni 2009

Studienanmeldedaten

Zuerst eingereicht

23. Februar 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Februar 2006

Zuerst gepostet (Schätzen)

27. Februar 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

16. Juni 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juni 2011

Zuletzt verifiziert

1. Juni 2011

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D3569C00011
  • PLANET II

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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