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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00296400
First received: February 23, 2006
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Drug: Rosuvastatin
Drug: Atorvastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Urinary Protein/Creatinine Ratio at Week 52 [LOCF] [ Time Frame: Assessed at baseline and Week 52 (LOCF) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Urinary Protein/Creatinine Ratio at Week 26. [ Time Frame: Assessed at baseline and Week 26 ] [ Designated as safety issue: No ]
    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.

  • Urinary Albumin/Creatinine Ratio at Week 26 [ Time Frame: Assessed at baseline and Week 26 ] [ Designated as safety issue: No ]
    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.

  • Urinary Albumin/Creatinine Ratio at Week 52 [LOCF] [ Time Frame: Assessed at baseline and Week 52 [LOCF] ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 [ Time Frame: Assessed at baseline and Week 26 ] [ Designated as safety issue: No ]
    The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.

  • Change From Baseline in eGFR at Week 52 [LOCF] [ Time Frame: Assessed at baseline and Week 52 [LOCF] ] [ Designated as safety issue: No ]
    The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26. [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • 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 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • 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 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • 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 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]

    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.

    )


  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.)

  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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.)


Enrollment: 237
Study Start Date: February 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosuvastatin
    Other Name: Crestor
    Drug: Atorvastatin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296400

  Show 107 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00296400     History of Changes
Other Study ID Numbers: D3569C00011, PLANET II
Study First Received: February 23, 2006
Results First Received: March 22, 2010
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration
Bulgaria: Drug Agency
Romania: Ministry of Health and the Family
Italy: National Institute of Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Canada: Health Protection Branch
Denmark: Federal Institute for Drugs and Medicinal Devices
Brazil: Agencia Nacional de Viglancia Sanitaria
Mexico: Comision Federal para la Proteccion Contra Riesgos Sanitarios
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
Hyperlipidemia
Proteinuria
Diabetes Mellitus

Additional relevant MeSH terms:
Hyperlipidemias
Proteinuria
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Atorvastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014