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临床试验/NCT00296400
NCT00296400已完成2 期

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 Non-diabetic Patients With Moderate Proteinuria

AstraZeneca105 个研究点 分布在 6 个国家目标入组 237 人开始时间: 2006年2月1日最近更新:
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试验速览

阶段
2 期
状态
已完成
发起方
AstraZeneca
入组人数
237
试验地点
105
主要终点
Urinary Protein/Creatinine Ratio at Week 52 [LOCF]
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •greater than or equal to 18 years of age
  • •Hyperlipidemia
  • •Urinary protein

排除标准

  • •Previous rosuvastatin treatment < 6 months prior to Visit 1
  • •Statin intolerance
  • •Severe hypertension

结局指标

主要结局

Urinary Protein/Creatinine Ratio at Week 52 [LOCF]

时间窗: Assessed at baseline and Week 52 (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.

次要结局

  • Urinary Protein/Creatinine Ratio at Week 26.(Assessed at baseline and Week 26)
  • Urinary Albumin/Creatinine Ratio at Week 26(Assessed at baseline and Week 26)
  • Urinary Albumin/Creatinine Ratio at Week 52 [LOCF](Assessed at baseline and Week 52 [LOCF])
  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26(Assessed at baseline and Week 26)
  • Change From Baseline in eGFR at Week 52 [LOCF](Assessed at baseline and Week 52 [LOCF])
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.(baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.(52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C(52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26(26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52(52 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26(Baseline and 26 weeks)
  • Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52(Baseline and 52 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26(Baseline and 26 weeks)
  • Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52(Baseline and 52 weeks)

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (105)

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