Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 weeks - POLARIS

Study identifier:4522IL/0106

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 26-week, double blind, randomised, multi-centre, phase IIIb, parallel group study to compare the efficacy and safety of rosuvastatin (40 mg) with atorvastatin (80 mg) in subjects with hypercholesterolaemia and coronary heart disease or CHD risk equivalents

Medical condition

Hypercholesterolemia

Phase

Phase 3

Healthy volunteers

Study drug

Rosuvastatin, Atorvastatin

Sex

All

Actual Enrollment

Study type

Interventional

Age

45 Years - 75 Years

Date

Study Start Date: 01 Apr 2003

Primary Completion Date: -

Study Completion Date: 01 Sept 2004

Study design

Allocation: None
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 rosuvastatin (40 mg)	Drug: Rosuvastatin 40mg Other Name: Crestor
Active Comparator: 2 atorvastatin (80 mg)	Drug: Atorvastatin 80mg Other Name: Lipitor

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1575&filename=CSR-4522IL-0106.pdf
Download
CSR-4522IL-0106.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

null AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

null AstraZeneca Information, (Outside US)

001-800-236-9933

Investigators

Principal Investigator

Dr. Lawrence Leiter

St Michaels hospital, Canada