Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks

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..

Completed

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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rosuvastatin

Drug

40mg

Other names: Crestor

atorvastatin

Drug

80mg

Other names: Lipitor

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: POLARIS

Important dates

Study start: 2003
Study completion: 2004
First posted: Apr 7, 2008
Registry last updated: Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed