Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks (POLARIS)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00653588
First received: April 2, 2008
Last updated: March 13, 2009
Last verified: March 2009
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Purpose
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..
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Coronary Heart Disease |
Drug: Rosuvastatin Drug: Atorvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 Outcome Measures:
- To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8
| Study Start Date: | April 2003 |
| Study Completion Date: | September 2004 |
| 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
|
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Elisabeth Björk, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00653588 History of Changes |
| Other Study ID Numbers: | 4522IL/0106, D3569C00005 |
| Study First Received: | April 2, 2008 |
| Last Updated: | March 13, 2009 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Denmark: Danish Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Sweden: Medical Products Agency |
Keywords provided by AstraZeneca:
|
Cholesterol low density lipoproteins Hypercholesterolemia Coronary Heart Disease |
Rosuvastatin Crestor Atorvastatin Lipitor |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Hypercholesterolemia Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Atorvastatin Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013