Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks - Full Text View

Purpose

The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..

Condition	Intervention	Phase
Hypercholesterolemia Coronary Heart Disease	Drug: Rosuvastatin Drug: Atorvastatin	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 26-Week, Double Blind, Randomised, Multi-Centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin (40 mg) With Atorvastatin (80 mg) in Subjects With Hypercholesterolaemia and Coronary Heart Disease or CHD Risk Equivalents

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin Atorvastatin calcium trihydrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the efficacy of rosuvastatin with atorvastatin by assessing the percentage change from baseline to week 8 in LDL-C concentrations in subjects with hypercholesterolaemia and CHD or CHD risk equivalents.

Secondary Outcome Measures:

To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8


Study Start Date:	April 2003
Study Completion Date:	September 2004

Arms	Assigned Interventions
Experimental: 1 rosuvastatin (40 mg)	Drug: Rosuvastatin 40mg Other Name: Crestor
Active Comparator: 2 atorvastatin (80 mg)	Drug: Atorvastatin 80mg Other Name: Lipitor

Eligibility


Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
Fasting LDL-C concentrations at Visit 1 as defined in the protocol.

Exclusion Criteria:

History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
Severe congestive cardiac failure (as defined by the protocol - Appendix I).
Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653588

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Dr. Lawrence Leiter	St Michaels hospital, Canada

More Information


Responsible Party:	Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00653588 History of Changes
Other Study ID Numbers:	4522IL/0106 D3569C00005
Study First Received:	April 2, 2008
Last Updated:	March 13, 2009
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Denmark: Danish Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Sweden: Medical Products Agency

Keywords provided by AstraZeneca:


Cholesterol low density lipoproteins Hypercholesterolemia Coronary Heart Disease	Rosuvastatin Crestor Atorvastatin Lipitor

Additional relevant MeSH terms:


Heart Diseases Hypercholesterolemia Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases	Arteriosclerosis Arterial Occlusive Diseases Rosuvastatin Calcium Atorvastatin Calcium Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 30, 2016

Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks (POLARIS)