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

Hypercholesterolemia Clinical Trial

— POLARIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653588
• Other study ID #: 4522IL/0106
• Secondary ID: D3569C00005
• Status: Completed
• Phase: Phase 3
• First received: April 2, 2008
• Last updated: March 13, 2009
• Start date: April 2003
• Est. completion date: September 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin
40mg
• Atorvastatin
80mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8