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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00296374

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 patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Rosuvastatin Drug: Atorvastatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 Diabetic Patients With Moderate Proteinuria

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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 in patients with Type 1 or 2 diabetes, moderate proteinuria and hypercholesterolemia. [ Time Frame: assessed from baseline to Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate change in urinary protein/creatinine ratio, and safety. [ Time Frame: Assessed at Week 26 ] [ Designated as safety issue: No ]
Evaluate the change in urinary albumin/creatinine ratio [ Time Frame: assessed at at Weeks 26 & 52 ] [ Designated as safety issue: No ]
Evaluate the relationship between renal effects and lipid changes [ Time Frame: Assessed at Weeks 26 & 52 ] [ Designated as safety issue: No ]
Evaluate the change in glomerular filtration rate [ Time Frame: Assessed at Weeks 26 & 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	345
Study Start Date:	January 2006
Study Completion Date:	March 2009

Arms	Assigned Interventions
1: Experimental Rosuvastatin 10 mg	Drug: Rosuvastatin 10 mg oral dose administered once daily for 52 weeks
2: Experimental Rosuvastatin 40 mg	Drug: Rosuvastatin 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
3: Active Comparator Atorvastatin 80 mg	Drug: Atorvastatin 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks

Eligibility

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

Criteria

Inclusion Criteria:

hyperlipidemia
urinary protein
diabetes

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296374

Show 116 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Crestor Medical Science Director, MD

AstraZeneca

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	D3569C00007, PLANET 1
Study First Received:	February 23, 2006
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00296374 History of Changes
Health Authority:	United States: Food and Drug Administration; Bulgaria: Bulgarian Drug Agency; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Italy: National Institute of Health; Canada: Health Canada; Romania: Ministry of Public Health; Brazil: National Health Surveillance Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by AstraZeneca:

Hyperlipidemia
Proteinuria
Diabetes Mellitus

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Urological Manifestations
Signs and Symptoms
Proteinuria
Rosuvastatin
Urologic Diseases
Therapeutic Uses
Glucose Metabolism Disorders
Atorvastatin

ClinicalTrials.gov processed this record on February 04, 2010