Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease - Full Text View

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00296374

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 patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Rosuvastatin Drug: Atorvastatin	Phase II

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 Diabetic Patients With Moderate Proteinuria

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. [ Time Frame: Assessed at Week 52, Last observation carried forward (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 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 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 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 ]
Change From Baseline in eGFR at Week 52 [LOCF] [ Time Frame: Assessed at Baseline and Week 52 [LOCF] ] [ Designated as safety issue: No ]
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes [ 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 (LOCF).
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC [ Time Frame: Assessed at 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C] [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C] [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C] [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG] [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1] [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1 [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB] [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio [ 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB [ 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
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio [ 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
Relationship Between Renal Effects and Lipid Changes: eGFR and TC [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and TC [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and TG [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and TG [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB [ Time Frame: 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
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio [ Time Frame: 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.
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio [ Time Frame: 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

Enrollment:	353
Study Start Date:	February 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Rosuvastatin 10 mg	Drug: Rosuvastatin 10 mg oral dose administered once daily for 52 weeks Other Name: Crestor
Experimental: 2 Rosuvastatin 40 mg	Drug: Rosuvastatin 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks Other Name: Crestor
Active Comparator: 3 Atorvastatin 80 mg	Drug: Atorvastatin 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks Other Name: Lipitor

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

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00296374 History of Changes
Other Study ID Numbers:	D3569C00007, PLANET 1
Study First Received:	February 23, 2006
Results First Received:	March 3, 2010
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration; Bulgaria: Bulgarian Drug Agency; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Italy: National Institute of Health; Canada: Health Canada; Romania: Ministry of Public Health; Brazil: National Health Surveillance Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Mexico: Federal Commission for Sanitary Risks Protection