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”

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 Type: Interventional

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

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • 10 mg oral dose administered once daily for 52 weeks
• Drug: Rosuvastatin
  • 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
• Drug: Atorvastatin
  • 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Rosuvastatin 10 mg
• Experimental: 2
  • Rosuvastatin 40 mg
• Active Comparator: 3
  • Atorvastatin 80 mg

Primary Measures

• 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.
  • Time Frame: assessed from baseline to Week 52
    Safety Issue?: No

Secondary Measures

• Evaluate change in urinary protein/creatinine ratio, and safety.
  • Time Frame: Assessed at Week 26
    Safety Issue?: No
• Evaluate the change in urinary albumin/creatinine ratio
  • Time Frame: assessed at at Weeks 26 & 52
    Safety Issue?: No
• Evaluate the relationship between renal effects and lipid changes
  • Time Frame: Assessed at Weeks 26 & 52
    Safety Issue?: No
• Evaluate the change in glomerular filtration rate
  • Time Frame: Assessed at Weeks 26 & 52
    Safety Issue?: No

Inclusion Criteria:

• hyperlipidemia
• urinary protein
• diabetes

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Crestor Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00296374

Study ID Number: D3569C00007

ClinicalTrials.gov Identifier: NCT00296374

Health Authority: United States: Food and Drug Administration

AstraZeneca Clinical Trial Information - Outside US