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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-09-30

Brief Summary

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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..

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Detailed Description

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Conditions

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Hypercholesterolemia Coronary Heart Disease

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

rosuvastatin (40 mg)

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

40mg

2

atorvastatin (80 mg)

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

80mg

Interventions

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Rosuvastatin

40mg

Intervention Type DRUG

Atorvastatin

80mg

Intervention Type DRUG

Other Intervention Names

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Crestor Lipitor

Eligibility Criteria

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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).

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No