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

August 30, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
353

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • La Plata, Argentina
        • Reasearch Site
      • Moron, Argentina
        • Research Site
      • Quilmes, Argentina
        • Research Site
  • Brazil
      • Curitiba, Brazil
        • Research Site
      • Fortaleza, Brazil
        • Research Site
      • Goiania, Brazil
        • Research Site
      • Recife, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Bulgaria
      • Burgas, Bulgaria
        • Research Site
      • Gabrovo, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
      • Veliko Tarnovo, Bulgaria
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • Courtice, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Oshawa, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Richmond Hill, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
      • Thunder Bay, Ontario, Canada
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Blegdamsvej 9, Denmark
        • Research Site
      • Farso, Denmark
        • Research Site
      • Gentofte, Denmark
        • Research Site
      • Hillerod, Denmark
        • Research Site
      • Hvidovre, Denmark
        • Research Site
      • Koge, Denmark
        • Research Site
  • France
      • Annonay, France
        • Research Site
      • Besançon, France
        • Research Site
      • Bondy, France
        • Research Site
      • Colmar, France
        • Research Site
      • Corbeil Essonnes, France
        • Research Site
      • Corsept, France
        • Research Site
      • Creil Cedex, France
        • Research Site
      • Grenoble Cedex, France
        • Research Site
      • La Chapelle Sur Erdre, France
        • Research Site
      • Nantes, France
        • Research Site
      • Paris, France
        • Research Site
      • Pessac, France
        • Research Site
      • Quimper, France
        • Research Site
  • Hungary
      • Baja, Hungary
        • Research Site
      • Balatonfured, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Hodmeztvasarhely, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Keszthely, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Mosonmagyarovar, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Szolnok, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
      • Tatabanya, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Italy
      • Bergamo, Italy
        • Research Site
      • Cagliari, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • San Giovanni Rotondo, Italy
        • Research Site
      • Sassari, Italy
        • Research Site
      • Treviglio, Italy
        • Research Site
    • CT
      • Acireale, CT, Italy
        • Research Site
    • FI
      • Firenze, FI, Italy
        • Research Site
    • RM
      • Roma, RM, Italy
        • Research Site
    • VE
      • Sottomarnia Di Chioggia, VE, Italy
        • Research Site
  • Mexico
      • Aguascalientes, Mexico
        • Research Site
      • Cauntla, Mexico
        • Research Site
      • Distrito Federal, Mexico
        • Research Site
      • Durango, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Saltillo, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
      • Zapopan, Mexico
        • Research Site
  • Romania
      • Baia Mare, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Lasi, Romania
        • Research Site
      • Targu Mures, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
  • United States
    • Arizona
      • Avondale, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
    • Arkansas
      • Jonesboro, Arkansas, United States
        • Research Site
    • California
      • Pasadena, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
      • West Hills, California, United States
        • Research Site
    • Florida
      • Hollywood, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Augusta, Georgia, United States
        • Research Site
    • Kansas
      • Topeka, Kansas, United States
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • New York
      • Orchard Park, New York, United States
        • Research Site
      • Stony Brook, New York, United States
        • Research Site
    • North Carolina
      • Winston Salem, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Kettering, Ohio, United States
        • Research Site
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Ogden, Utah, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hyperlipidemia
  • urinary protein
  • diabetes

Exclusion Criteria:

  • previous rosuvastatin treatment < 6 months prior to Visit 1
  • statin intolerance
  • severe hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2
Rosuvastatin 40 mg
Drug: Rosuvastatin
10 mg oral dose administered once daily for 52 weeks
Other Names:
  • Crestor
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 Names:
  • Crestor
Experimental: 1
Rosuvastatin 10 mg
Drug: Rosuvastatin
10 mg oral dose administered once daily for 52 weeks
Other Names:
  • Crestor
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 Names:
  • 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 Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
Time Frame: Assessed at Week 52, Last observation carried forward (LOCF)
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.
Assessed at Week 52, Last observation carried forward (LOCF)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary Protein/Creatinine Ratio at Week 26.
Time Frame: Assessed at Week 26
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.
Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 26
Time Frame: Assessed at Week 26
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.
Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Time Frame: Assessed at Week 52 LOCF
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.
Assessed at Week 52 LOCF
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
Time Frame: Assessed at Baseline and Week 26
Assessed at Baseline and Week 26
Change From Baseline in eGFR at Week 52 [LOCF]
Time Frame: Assessed at Baseline and Week 52 [LOCF]
Assessed at Baseline and Week 52 [LOCF]
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes
Time Frame: 52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).
52 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC
Time Frame: Assessed at 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Assessed at 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
Time Frame: 52 Weeks
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
Time Frame: 52 Weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
Time Frame: 52 Weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
Time Frame: 26 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
Time Frame: 52 weeks
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: AstraZeneca Crestor Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3569C00007
  • PLANET 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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