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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Coronary Heart Disease; Hypercholesterolemia

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653588

4522IL/0106

D3569C00005

Details and patient eligibility

About

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..

Sex: All

Ages: 45 to 75 years old

Volunteers: No 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).

Trial design

0 participants in 2 patient groups

1

Experimental group

Description:

rosuvastatin (40 mg)

Treatment:

Drug: Rosuvastatin

2

Active Comparator group

Description:

atorvastatin (80 mg)

Treatment:

Drug: Atorvastatin