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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014