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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00296400

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Rosuvastatin Drug: Atorvastatin	Phase II

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	345
Study Start Date:	January 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296400

Show 107 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Crestor Medical Science Director, MD

AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D3569C00011, PLANET II
Study First Received:	February 23, 2006
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00296400
Health Authority:	United States: Food and Drug Administration; Bulgaria: Drug Agency; Romania: Ministry of Health and the Family; Italy: National Institute of Health; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Canada: Health Protection Branch; Denmark: Federal Institute for Drugs and Medicinal Devices; Brazil: Agencia Nacional de Viglancia Sanitaria; Mexico: Comision Federal para la Proteccion Contra Riesgos Sanitarios; South Africa: Medicines Control Council

Keywords provided by AstraZeneca:

Hyperlipidemia
Proteinuria
Diabetes Mellitus

Study placed in the following topic categories:

Hyperlipidemias
Metabolic Diseases
Urination Disorders
Diabetes Mellitus
Signs and Symptoms
Proteinuria
Rosuvastatin

Urologic Diseases
Kidney Diseases
Metabolic disorder
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Urological Manifestations
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009