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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653588

Acronym

POLARIS

Enrollment

Unknown

Registered

2008-04-07

Start date

2003-04-30

Completion date

2004-09-30

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Hypercholesterolemia

Keywords

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

Brief summary

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..

Interventions

DRUGRosuvastatin

40mg

DRUGAtorvastatin

80mg

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026