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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00296400 |
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 |
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Hyperlipidemia |
Drug: Rosuvastatin Drug: Atorvastatin |
Phase II |
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 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Crestor Medical Science Director, MD | AstraZeneca |
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 |
Hyperlipidemia Proteinuria Diabetes Mellitus |
Hyperlipidemias Metabolic Diseases Urination Disorders Diabetes Mellitus Signs and Symptoms Proteinuria Rosuvastatin |
Urologic Diseases Kidney Diseases Metabolic disorder Dyslipidemias Atorvastatin Lipid Metabolism Disorders |
Antimetabolites Urological Manifestations Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |