Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks | NCT00653588

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

NCT00653588

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Hypercholesterolemia
Coronary Heart Disease

Interventions

Rosuvastatin
Atorvastatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D3569C00005

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Sep 2004Actual

First Submitted Date

Apr 2, 2008

First Submission Date that Met QC Criteria

Apr 4, 2008

First Posted Date

Apr 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2009

Last Update Posted Date

Mar 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	rosuvastatin (40 mg)	Drug: Rosuvastatin
2	Active Comparator	atorvastatin (80 mg)	Drug: Atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	40mg	1	Crestor

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Lawrence Leiter	St Michaels hospital, Canada	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia
D003327	Coronary Disease

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided