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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00296400
Recruitment Status : Completed
First Posted : February 27, 2006
Results First Posted : December 30, 2010
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hyperlipidemia
Interventions Drug: Rosuvastatin
Drug: Atorvastatin
Enrollment 237
Recruitment Details 797 patients entered the study with moderate proteinuria and hypercholesterolemia and were receiving stable treatment with angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs) for 3 or more months prior to Visit 1. The study was conducted at 114 participating centers in 11 countries.
Pre-assignment Details 237 patients [pts] completed the 8-week lead-in period and were randomized. The most common reasons for discontinuation during the lead in period included incorrect enrollment (466 pts), development of study-specific discontinuation criteria (41 pts), and voluntary discontinuation (29 pts). 189 patients completed the study.
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 70 87 80
Completed 53 69 67
Not Completed 17 18 13
Reason Not Completed
Adverse Event             7             7             7
Withdrawal by Subject             5             6             2
Incorrect enrollment             2             0             0
Protocol Violation             1             1             1
Lost to Follow-up             1             1             2
Study specific discontinuation criteria             0             0             1
Visit 10 was performed earlier             0             1             0
Pregnancy             1             2             0
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 70 87 80 237
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 87 participants 80 participants 237 participants
18 to 49 years 34 44 42 120
50 to 64 years 31 31 30 92
>=65 years 5 12 8 25
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 87 participants 80 participants 237 participants
Female
28
  40.0%
35
  40.2%
31
  38.8%
94
  39.7%
Male
42
  60.0%
52
  59.8%
49
  61.3%
143
  60.3%
Estimated glomerular filtration rate [eGFR]  
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 70 participants 87 participants 80 participants 237 participants
78.315  (28.0653) 76.774  (30.3878) 71.464  (30.0156) 75.419  (29.6012)
Urine albumin/creatinine ratio  
Mean (Standard Deviation)
Unit of measure:  Mg/g
Number Analyzed 70 participants 87 participants 80 participants 237 participants
1023.165  (720.0251) 1167.368  (865.4584) 1069.103  (720.8011) 1091.263  (775.1889)
Urine protein/creatinine ratio  
Mean (Standard Deviation)
Unit of measure:  Mg/g
Number Analyzed 70 participants 87 participants 80 participants 237 participants
1301.163  (832.7398) 1487.131  (1068.0642) 1439.720  (991.2295) 1416.023  (975.7636)
1.Primary Outcome
Title Urinary Protein/Creatinine Ratio at Week 52 [LOCF]
Hide Description 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.
Time Frame Assessed at baseline and Week 52 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 65 80 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.938
(0.725 to 1.212)
1.082
(0.927 to 1.262)
0.759
(0.636 to 0.905)
2.Secondary Outcome
Title Urinary Protein/Creatinine Ratio at Week 26.
Hide Description 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.
Time Frame Assessed at baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 59 76 70
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.932
(0.721 to 1.203)
1.057
(0.898 to 1.244)
0.762
(0.631 to 0.921)
3.Secondary Outcome
Title Urinary Albumin/Creatinine Ratio at Week 26
Hide Description 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.
Time Frame Assessed at baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 60 76 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.850
(0.631 to 1.143)
0.946
(0.789 to 1.135)
0.731
(0.601 to 0.889)
4.Secondary Outcome
Title Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Hide Description 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.
Time Frame Assessed at baseline and Week 52 [LOCF]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 65 80 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.879
(0.652 to 1.185)
0.967
(0.814 to 1.148)
0.719
(0.587 to 0.882)
5.Secondary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
Hide Description The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.
Time Frame Assessed at baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 60 77 72
Mean (Standard Deviation)
Unit of Measure: mL/min
1.39  (15.431) -3.41  (13.228) -1.61  (9.494)
6.Secondary Outcome
Title Change From Baseline in eGFR at Week 52 [LOCF]
Hide Description The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.
Time Frame Assessed at baseline and Week 52 [LOCF]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 65 80 75
Mean (Standard Deviation)
Unit of Measure: mL/min
-2.71  (13.083) -3.30  (12.325) -1.74  (13.964)
7.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.
Hide Description 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.)
Time Frame baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 70 205
Measure Type: Number
Unit of Measure: Correlation coefficient
0.17601 0.21701 0.19643
8.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.
Hide Description 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.)
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 64 185
Measure Type: Number
Unit of Measure: Correlation coefficient
0.20462 0.03480 0.16077
9.Secondary Outcome
Title 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
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 69 204
Measure Type: Number
Unit of Measure: Correlation coefficient
0.14302 0.24393 0.17632
10.Secondary Outcome
Title Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C
Hide Description 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.)
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 62 183
Measure Type: Number
Unit of Measure: Correlation coefficient
0.16868 -0.09428 0.10679
11.Secondary Outcome
Title 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
Hide Description 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.)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 69 204
Measure Type: Number
Unit of Measure: Correlation coefficient
0.18055 0.24987 0.22094
12.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 62 183
Measure Type: Number
Unit of Measure: Correlation coefficient
0.20346 0.18041 0.20818
13.Secondary Outcome
Title 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
Hide Description

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.

)

Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 69 204
Measure Type: Number
Unit of Measure: Correlation coefficient
0.16206 0.20032 0.17628
14.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 62 183
Measure Type: Number
Unit of Measure: Correlation coefficient
0.20386 -0.04698 0.14495
15.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 70 205
Measure Type: Number
Unit of Measure: Correlation coefficient
0.15348 -0.06049 0.10089
16.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 64 185
Measure Type: Number
Unit of Measure: Correlation coefficient
0.20659 0.23989 0.21728
17.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 69 204
Measure Type: Number
Unit of Measure: Correlation coefficient
0.04652 0.06344 0.04149
18.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 62 183
Measure Type: Number
Unit of Measure: Correlation coefficient
0.03957 -0.17644 -0.01549
19.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 69 204
Measure Type: Number
Unit of Measure: Correlation coefficient
0.06383 0.12687 0.07462
20.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 62 183
Measure Type: Number
Unit of Measure: Correlation coefficient
0.05881 -0.20262 -0.01340
21.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 135 69 204
Measure Type: Number
Unit of Measure: Correlation coefficient
0.06794 0.05410 0.05465
22.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 62 183
Measure Type: Number
Unit of Measure: Correlation coefficient
0.07188 -0.16669 0.00955
23.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 131 67 198
Measure Type: Number
Unit of Measure: Correlation coefficient
0.12595 0.05628 0.13754
24.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 62 178
Measure Type: Number
Unit of Measure: Correlation coefficient
0.19626 0.09835 0.18349
25.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 131 67 198
Measure Type: Number
Unit of Measure: Correlation coefficient
0.18504 0.17259 0.19146
26.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 62 178
Measure Type: Number
Unit of Measure: Correlation coefficient
0.18473 -0.02690 0.12496
27.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 131 67 198
Measure Type: Number
Unit of Measure: Correlation coefficient
0.10698 0.13814 0.11414
28.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 62 178
Measure Type: Number
Unit of Measure: Correlation coefficient
0.05859 -0.12938 -0.00540
29.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 72 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.18188 0.17503 0.18566
30.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 65 186
Measure Type: Number
Unit of Measure: Correlation coefficient
0.23734 0.01311 0.17958
31.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 71 207
Measure Type: Number
Unit of Measure: Correlation coefficient
0.14783 0.21561 0.16899
32.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
0.20285 -0.13565 0.12568
33.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 71 207
Measure Type: Number
Unit of Measure: Correlation coefficient
0.23547 0.25043 0.25208
34.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
0.17479 0.18677 0.18203
35.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 71 207
Measure Type: Number
Unit of Measure: Correlation coefficient
0.16080 0.17150 0.16578
36.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
0.24107 -0.08640 0.16525
37.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 72 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.11526 -0.06890 0.07248
38.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 65 186
Measure Type: Number
Unit of Measure: Correlation coefficient
0.21730 0.21151 0.21477
39.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 71 207
Measure Type: Number
Unit of Measure: Correlation coefficient
0.02506 0.02201 0.01860
40.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
0.08954 -0.20870 0.01926
41.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 71 207
Measure Type: Number
Unit of Measure: Correlation coefficient
0.05037 0.09779 0.05936
42.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
0.10365 -0.24717 0.01386
43.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 136 71 207
Measure Type: Number
Unit of Measure: Correlation coefficient
0.04955 0.02740 0.03798
44.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
0.11997 -0.21073 0.03955
45.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 131 68 199
Measure Type: Number
Unit of Measure: Correlation coefficient
0.16499 0.02609 0.15049
46.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 63 179
Measure Type: Number
Unit of Measure: Correlation coefficient
0.20021 0.12953 0.18870
47.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 131 68 199
Measure Type: Number
Unit of Measure: Correlation coefficient
0.18720 0.16167 0.18717
48.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
Hide Description 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.)
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 63 179
Measure Type: Number
Unit of Measure: Correlation coefficient
0.21082 -0.04379 0.14085
49.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 131 68 199
Measure Type: Number
Unit of Measure: Correlation coefficient
0.10258 0.13505 0.11103
50.Secondary Outcome
Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 63 179
Measure Type: Number
Unit of Measure: Correlation coefficient
0.08108 -0.16753 0.00479
51.Secondary Outcome
Title Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 72 209
Measure Type: Number
Unit of Measure: Correlation coefficient
0.06641 -0.07964 0.02900
52.Secondary Outcome
Title Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 65 186
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.15721 0.16110 -0.05794
53.Secondary Outcome
Title Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 71 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.02679 -0.07603 -0.00171
54.Secondary Outcome
Title Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.15731 0.15368 -0.06310
55.Secondary Outcome
Title Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 71 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.01684 0.01755 0.01758
56.Secondary Outcome
Title Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
0.14080 0.02750 0.09472
57.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 71 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.06029 -0.08151 0.02283
58.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.19532 0.14967 -0.09001
59.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 72 209
Measure Type: Number
Unit of Measure: Correlation coefficient
0.04160 0.00531 0.03430
60.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 65 186
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.12643 0.00486 -0.08301
61.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 71 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.08194 -0.06576 0.04477
62.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.23597 0.19933 -0.10205
63.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 71 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.04858 -0.05535 0.02023
64.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.20805 0.18299 -0.07681
65.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 137 71 208
Measure Type: Number
Unit of Measure: Correlation coefficient
0.08263 -0.06860 0.04337
66.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 121 63 184
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.23887 0.17170 -0.10817
67.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 132 68 200
Measure Type: Number
Unit of Measure: Correlation coefficient
0.13029 0.17554 0.14191
68.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 63 179
Measure Type: Number
Unit of Measure: Correlation coefficient
0.11047 0.07751 0.08580
69.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 132 68 200
Measure Type: Number
Unit of Measure: Correlation coefficient
0.06098 -0.03181 0.03861
70.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 63 179
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.11217 0.11006 -0.03932
71.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Hide Description 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.)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 132 68 200
Measure Type: Number
Unit of Measure: Correlation coefficient
0.02907 -0.09476 -0.00160
72.Secondary Outcome
Title Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Hide Description 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.)
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rosuvastatin Atorvastatin All Treatments
Hide Arm/Group Description:
Rosuvastatin Treatments pooled
Atorvastatin Treatment
All Treatments pooled
Overall Number of Participants Analyzed 116 63 179
Measure Type: Number
Unit of Measure: Correlation coefficient
-0.15415 0.10486 -0.06121
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/69 (14.49%)   6/87 (6.90%)   5/80 (6.25%) 
Cardiac disorders       
Cardiac Failure  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Cardiac Failure Congestive  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Gastrointestinal disorders       
Enterocolitis  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Dyspepsia  1  0/69 (0.00%)  0/87 (0.00%)  1/80 (1.25%) 
Gastritis  1  0/69 (0.00%)  0/87 (0.00%)  1/80 (1.25%) 
Gastrointestinal Haemorrhage  1  0/69 (0.00%)  1/87 (1.15%)  0/80 (0.00%) 
General disorders       
Oedema Peripheral  1  0/69 (0.00%)  1/87 (1.15%)  0/80 (0.00%) 
Infections and infestations       
Bronchitis  1  2/69 (2.90%)  0/87 (0.00%)  1/80 (1.25%) 
Injury, poisoning and procedural complications       
Lumbar Vertebral Fracture  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Humerus Fracture  1  0/69 (0.00%)  1/87 (1.15%)  0/80 (0.00%) 
Meniscus Lesion  1  0/69 (0.00%)  1/87 (1.15%)  0/80 (0.00%) 
Metabolism and nutrition disorders       
Fluid Retention  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral Disc Protrusion  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Musculoskeletal Chest Pain  1  0/69 (0.00%)  0/87 (0.00%)  1/80 (1.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Transitional Cell Carcinoma  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Breast Cancer  1  0/69 (0.00%)  0/87 (0.00%)  1/80 (1.25%) 
Nervous system disorders       
Hypertensive Encephalopathy  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Intracranial Aneurysm  1  0/69 (0.00%)  1/87 (1.15%)  0/80 (0.00%) 
Renal and urinary disorders       
Renal Colic  1  1/69 (1.45%)  0/87 (0.00%)  0/80 (0.00%) 
Nephrotic Syndrome  1  0/69 (0.00%)  1/87 (1.15%)  0/80 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/69 (0.00%)  0/87 (0.00%)  1/80 (1.25%) 
Vascular disorders       
Hypertension  1  0/69 (0.00%)  1/87 (1.15%)  0/80 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rosuvastatin 10 mg Rosuvastatin 40 mg Atorvastatin 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/69 (21.74%)   16/87 (18.39%)   17/80 (21.25%) 
Gastrointestinal disorders       
Nausea  1  2/69 (2.90%)  6/87 (6.90%)  0/80 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  3/69 (4.35%)  6/87 (6.90%)  7/80 (8.75%) 
Bronchitis  1  4/69 (5.80%)  0/87 (0.00%)  0/80 (0.00%) 
Blood Creatine Phosphokinase Increased  1  3/69 (4.35%)  3/87 (3.45%)  4/80 (5.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  4/69 (5.80%)  3/87 (3.45%)  5/80 (6.25%) 
Nervous system disorders       
Dizziness  1  0/69 (0.00%)  1/87 (1.15%)  4/80 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00296400    
Other Study ID Numbers: D3569C00011
PLANET II
First Submitted: February 23, 2006
First Posted: February 27, 2006
Results First Submitted: March 22, 2010
Results First Posted: December 30, 2010
Last Update Posted: June 16, 2011