ClinicalTrials.gg
Sign In
CompletedNCT00653588POLARISUpdated Mar 16, 2009

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

A Phase 3 interventional study of Rosuvastatin and Atorvastatin in Hypercholesterolemia and Coronary Heart Disease, sponsored by AstraZeneca. Completed. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-03-16.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Ages
45 Years to 75 Years
Sex
All
01

Study 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..

02

Conditions studied

  • Hypercholesterolemia
  • Coronary Heart Disease

Keywords

  • Cholesterol
  • low density lipoproteins
  • Hypercholesterolemia
  • Coronary Heart Disease
  • Rosuvastatin
  • Crestor
  • Atorvastatin
  • Lipitor
03

In context

Hypercholesterolemia

1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.

Browse Hypercholesterolemia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel assignment
Masking
Double

Study arms

  • Experimental
    1

    rosuvastatin (40 mg)

    Drug: Rosuvastatin

  • Active comparator
    2

    atorvastatin (80 mg)

    Drug: Atorvastatin

Interventions

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00653588
Lead sponsor
AstraZeneca
First posted
Apr 7, 2008
Start date
Apr 2003
Completion
Sep 2004
Last update
Mar 16, 2009

Study contacts

Dr. Lawrence Leiter
principal investigator · St Michaels hospital, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Rosuvastatin

Other studies in this condition

Hypercholesterolemia →

Other studies from this sponsor

AstraZeneca →

Start the discussion