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

NCT00296374 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2011-09-01

Study results available
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Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Crestor Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Denmark
  • France
  • Hungary
  • Italy
  • Mexico
  • Romania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00296374 on ClinicalTrials.gov