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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00653588

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 III

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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

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
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

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

No publications provided

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:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Atorvastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012