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

Condition(s) targeted: Hyperlipidemia

Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: AstraZeneca

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

Overall contact:
AstraZeneca Information, Phone: 800-236-9933

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.

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 Non-Diabetic Patients With Moderate Proteinuria

Study design: Treatment, Randomized, Double-Blind, 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 from baseline to Week 52 in non-diabetic patients with moderate proteinuria and hypercholesterolemia.

Secondary outcome: Evaluate change in urinary protein/creatinine ratio at Wk 26, change in urinary albumin/creatinine ratio at Wks 26 & 52, relationship between renal effects and lipid changes at Wks 26 & 52, change in glomerular filtration rate at Wks 26 & 52, and safety.

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

Criteria:

Inclusion Criteria:

- greater than or equal to 18 years of age

- Hyperlipidemia

- Urinary protein

Exclusion Criteria:

- Previous rosuvastatin treatment < 6 months prior to Visit 1

- Statin intolerance

- Severe hypertension

- Diabetes

AstraZeneca Information, Phone: 800-236-9933

Research Site, BLAGOEVGRAD, Bulgaria; Not yet recruiting

Research Site, BURGAS, Bulgaria; Recruiting

Research Site, GABROVO, Bulgaria; Recruiting

Research Site, PLEVEN, Bulgaria; Recruiting

Research Site, PLOVDIV, Bulgaria; Recruiting

Research Site, SOFIA, Bulgaria; Recruiting

Research Site, VARNA, Bulgaria; Recruiting

Research Site, VELIKO TURNOVO, Bulgaria; Recruiting

Research Site, FREDERICIA, Denmark; Recruiting

Research Site, HERLEV, Denmark; Recruiting

Research Site, HOLBAEK, Denmark; Not yet recruiting

Research Site, KOBENHAVN, Denmark; Recruiting

Research Site, ROSKILDE, Denmark; Recruiting

Research Site, VIBORG, Denmark; Recruiting

Research Site, BERLIN, Germany; Active, not recruiting

Research Site, CLOPPENBURG, Germany; Recruiting

Research Site, DEMMIN, Germany; Recruiting

Research Site, DUSSELDORF, Germany; Recruiting

Research Site, ELSENFELD, Germany; Recruiting

Research Site, GOTTINGEN, Germany; Active, not recruiting

Research Site, HANNOVER, Germany; Recruiting

Research Site, WURZBURG, Germany; Recruiting

Research Site, AJKA, Hungary; Recruiting

Research Site, BAJA, Hungary; Recruiting

Research Site, BALATONFURED, Hungary; Recruiting

Research Site, BUDAPEST, Hungary; Recruiting

Research Site, DEBRECEN, Hungary; Recruiting

Research Site, EGER, Hungary; Recruiting

Research Site, GY�R, Hungary; Recruiting

Research Site, GYULA, Hungary; Recruiting

Research Site, KESZTHELY, Hungary; Recruiting

Research Site, MISKOLC, Hungary; Recruiting

Research Site, NYIREGYHAZA, Hungary; Recruiting

Research Site, SZOLNOK, Hungary; Recruiting

Research Site, SZOMBATHELY, Hungary; Recruiting

Research Site, ZALAEGERSZEG, Hungary; Recruiting

Research Site, AGUASCALIENTES, Mexico; Not yet recruiting

Research Site, D.F, Mexico; Not yet recruiting

Research Site, DURANGO, Mexico; Recruiting

Research Site, SAN LUIS POTOS�, Mexico; Recruiting

Research Site, BUCURESTI, Romania; Recruiting

Research Site, CRAIOVA, Romania; Recruiting

Research Site, IASI, Romania; Recruiting

Research Site, BRASOV, Romania; Recruiting

Research Site, CONSTANTA, Romania; Recruiting

Research Site, SUCEAVA, Romania; Not yet recruiting

Research Site, CAPE TOWN, South Africa; Recruiting

Research Site, DURBAN, South Africa; Not yet recruiting

Research Site, PRETORIA, South Africa; Recruiting

Research Site, AVONDALE, Arizona, United States; Recruiting

Research Site, PHOENIX, Arizona, United States; Recruiting

Research Site, BERGAMO, BG, Italy; Recruiting

Research Site, BOLOGNA, BO, Italy; Recruiting

Research Site, BRESCIA, BS, Italy; Recruiting

Research Site, VANCOUVER, British Columbia, Canada; Not yet recruiting

Research Site, CLUJ NAPOCA, CLUJ, Romania; Recruiting

Research Site, ACIREALE, CT, Italy; Recruiting

Research Site, PASADENA, California, United States; Recruiting

Research Site, RIVERSIDE, California, United States; Recruiting

Research Site, MEXICO, DF, Mexico; Not yet recruiting

Research Site, FOGGIA, FG, Italy; Recruiting

Research Site, FIRENZE, FI, Italy; Recruiting

Research Site, CLEARWATER, Florida, United States; Active, not recruiting

Research Site, HOLLYWOOD, Florida, United States; Recruiting

Research Site, JACKSONVILLE, Florida, United States; Recruiting

Research Site, JOHANNESBURG, GAUTENG, South Africa; Recruiting

Research Site, AUGUSTA, Georgia, United States; Recruiting

Research Site, ZAPOPAN, JALISCO, Mexico; Recruiting

Research Site, TOPEKA, Kansas, United States; Recruiting

Research Site, CUERNAVACA, MORELOS, Mexico; Not yet recruiting

Research Site, COLUMBIA, Maryland, United States; Recruiting

Research Site, SPRINGFIELD, Massachusetts, United States; Recruiting

Research Site, DETROIT, Michigan, United States; Recruiting

Research Site, COLUMBIA, Missouri, United States; Recruiting

Research Site, ORCHARD PARK, New York, United States; Active, not recruiting

Research Site, ST JOHN'S, Newfoundland and Labrador, Canada; Not yet recruiting

Research Site, WINSTON SALEM, North Carolina, United States; Active, not recruiting

Research Site, OKLAHOMA CITY, Oklahoma, United States; Active, not recruiting

Research Site, COURTICE, Ontario, Canada; Recruiting

Research Site, EAST YORK, Ontario, Canada; Recruiting

Research Site, OAKVILLE, Ontario, Canada; Recruiting

Research Site, OSHAWA, Ontario, Canada; Recruiting

Research Site, RICHMOND HILL, Ontario, Canada; Recruiting

Research Site, SCARBOROUGH, Ontario, Canada; Recruiting

Research Site, THUNDER BAY, Ontario, Canada; Recruiting

Research Site, TORONTO, Ontario, Canada; Recruiting

Research Site, CURITIBA, PR, Brazil; Active, not recruiting

Research Site, PARMA, PR, Italy; Not yet recruiting

Research Site, PITTSBURGH, Pennsylvania, United States; Active, not recruiting

Research Site, GREENFIELD PARK, Quebec, Canada; Recruiting

Research Site, MONTREAL, Quebec, Canada; Recruiting

Research Site, REGGIO CALABRIA, RC, Italy; Recruiting

Research Site, SAO PAULO, SP, Brazil; Active, not recruiting

Research Site, SASSARI, SS, Italy; Recruiting

Research Site, COLUMBIA, South Carolina, United States; Recruiting

Research Site, TERAMO, TE, Italy; Recruiting

Research Site, TIMISOARA, TIMIS, Romania; Recruiting

Research Site, CASTELFRANCO VENETO, TV, Italy; Recruiting

Research Site, TREVISO, TV, Italy; Recruiting

Research Site, HOUSTON, Texas, United States; Active, not recruiting

Research Site, SAN ANTONIO, Texas, United States; Active, not recruiting

Research Site, MESTRE, VE, Italy; Recruiting

Research Site, RICHMOND, Virginia, United States; Recruiting

Research Site, PAROW, W CAPE, South Africa; Recruiting

Research Site, GIG HARBOR, Washington, United States; Active, not recruiting

Research Site, MILWAUKEE, Wisconsin, United States; Recruiting

Research Site, TORINO, to, Italy; Recruiting

AstraZeneca Clinical Trial Information - Outside US

Starting date: January 2006
Last updated: March 20, 2008