Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease

Condition(s) targeted: Diabetes Mellitus

Intervention: Rosuvastatin (Drug); Rosuvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Crestor Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Evaluate effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of change in urinary protein/creatinine ratio in patients with Type 1 or 2 diabetes, moderate proteinuria and hypercholesterolemia.

Secondary outcome:

Evaluate change in urinary protein/creatinine ratio, and safety.

Evaluate the change in urinary albumin/creatinine ratio

Evaluate the relationship between renal effects and lipid changes

Evaluate the change in glomerular filtration rate

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- hyperlipidemia

- urinary protein

- diabetes

Exclusion Criteria:

- previous rosuvastatin treatment < 6 months prior to Visit 1

- statin intolerance

- severe hypertension

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AstraZeneca Clinical Trial Information - Outside US

Starting date: January 2006
Ending date: April 2009
Last updated: May 1, 2008