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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia; Coronary Heart Disease

Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Dr. Lawrence Leiter, Principal Investigator, Affiliation: St Michaels hospital, Canada

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..

Clinical Details

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

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

Primary outcome: 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: To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8

Eligibility

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.

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).

Locations and Contacts

Additional Information

Starting date: April 2003
Last updated: March 13, 2009

Page last updated: August 23, 2015

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