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临床试验/NCT00296374
NCT00296374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 Diabetic Patients With Moderate Proteinuria

AstraZeneca3 个研究点 分布在 3 个国家目标入组 353 人开始时间: 2006年2月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
AstraZeneca
入组人数
353
试验地点
3
主要终点
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
研究概览研究设计入排标准研究组 & 干预措施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 patients with Type 1 or 2 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

  • •hyperlipidemia
  • •urinary protein

排除标准

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

研究组 & 干预措施

1

Experimental

Rosuvastatin 10 mg

干预措施: Rosuvastatin (Drug)

2

Experimental

Rosuvastatin 40 mg

干预措施: Rosuvastatin (Drug)

3

Active Comparator

Atorvastatin 80 mg

干预措施: Atorvastatin (Drug)

结局指标

主要结局

Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.

时间窗: 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.

次要结局

  • Urinary Protein/Creatinine Ratio at Week 26.(Assessed at Week 26)
  • Urinary Albumin/Creatinine Ratio at Week 26(Assessed at Week 26)
  • Urinary Albumin/Creatinine Ratio at Week 52 [LOCF](Assessed at 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 Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC(Assessed at 52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C](26 weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C](26 weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C](26 weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG](26 weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1](26 weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB](26 weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TC(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C(52 Weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TG(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB(52 weeks)
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio(52 weeks)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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