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

NCT00653588 | Completed Phase 3

• 2 other identifiers: 4522IL/0106D3569C00005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Hypercholesterolemia; Coronary Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 (1)

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

Study Arms (2)

1

EXPERIMENTAL

rosuvastatin (40 mg)

Drug: Rosuvastatin

2

ACTIVE COMPARATOR

atorvastatin (80 mg)

Drug: Atorvastatin

Interventions

Rosuvastatin DRUG

40mg

Also known as: Crestor

1

Atorvastatin DRUG

80mg

Also known as: Lipitor

2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Disease

Interventions

Rosuvastatin Calcium; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Dr. Lawrence Leiter

  St Michaels hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: April 1, 2003
• Study Completion: September 1, 2004
• Last Updated: March 16, 2009

Record last verified: 2009-03