Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease (PLANET 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00296374
First received: February 23, 2006
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.


Condition Intervention Phase
Diabetes Mellitus
Drug: Rosuvastatin
Drug: Atorvastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria

Resource links provided by NLM:


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

  Eligibility

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

Inclusion Criteria:

  • hyperlipidemia
  • urinary protein
  • diabetes

Exclusion Criteria:

  • previous rosuvastatin treatment < 6 months prior to Visit 1
  • statin intolerance
  • severe hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296374

  Show 116 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
  More Information

No publications provided

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Keywords provided by AstraZeneca:
Hyperlipidemia
Proteinuria
Diabetes Mellitus

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

ClinicalTrials.gov processed this record on April 21, 2014