LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes

Condition(s) targeted: Acute Coronary Syndromes

Intervention: rosuvastatin calcium (Drug); atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Crestor Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes

Official title: A 12-Week Randomized, Open-Label 3-Arm, Parallel Group, Multicenter Phase IIIb Study Comparing Efficacy and Safety of Rosuvastatin 20mg and 40mg With That of Atorvastatin 80 mg in Subjects With Acute Coronary Syndromes

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Reduction of LDL-C following 12 weeks of treatment

Secondary outcome: % change from baseline in LDL-C following 2 & 6 weeks of treatment; % change from baseline in TC, HDL-C, triglycerides, non-HDL-C, apolipoprotein A-1, apolipoprotein B, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, ApoB/Apo A-1 @ weeks 6 & 12

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal

reperfusion therapy

Exclusion Criteria:

- Previous Q-wave infarct within the last 4 weeks

- CK elevation not caused by myocardial injury

- uncontrolled hypertension at time of randomization

Research Site, San Jose, Costa Rica

Research Site, San Salvador, El Salvador

Research Site, Ayer, Morocco

Research Site, Panama City, Panama

Research Site, Torrance, California, United States

Research Site, San Diego, California, United States

Research Site, Bridgeport, Connecticut, United States

Research Site, Pensacola, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Safety Harbor, Florida, United States

Research Site, Tampa, Florida, United States

Research Site, Brandon, Florida, United States

Research Site, Atlantis, Florida, United States

Research Site, Lombard, Illinois, United States

Research Site, Peoria, Illinois, United States

Research Site, Chicago, Illinois, United States

Research Site, Aurora, Illinois, United States

Research Site, Melrose Park, Illinois, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Anderson, Indiana, United States

Research Site, Des Moines, Iowa, United States

Research Site, Louisville, Kentucky, United States

Research Site, Owensboro, Kentucky, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Covington, Louisiana, United States

Research Site, Towson, Maryland, United States

Research Site, Annapolis, Maryland, United States

Research Site, Pontiac, Michigan, United States

Research Site, Troy, Michigan, United States

Research Site, Ann Arbor, Michigan, United States

Research Site, Minneapolis, Minnesota, United States

Research Site, St. Paul, Minnesota, United States

Research Site, Tupelo, Mississippi, United States

Research Site, St. Louis, Missouri, United States

Research Site, Kansas City, Missouri, United States

Research Site, Kalispell, Montana, United States

Research Site, Newark, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

Research Site, Rochester, New York, United States

Research Site, Asheville, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Fairview Park, Ohio, United States

Research Site, Springfield, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Tulsa, Oklahoma, United States

Research Site, Portland, Oregon, United States

Research Site, Bend, Oregon, United States

Research Site, Danville, Pennsylvania, United States

Research Site, Memphis, Tennessee, United States

Research Site, Dallas, Texas, United States

Research Site, Amarillo, Texas, United States

Research Site, Beaumont, Texas, United States

Research Site, Lubbock, Texas, United States

Research Site, Chesapeake, Virginia, United States

Research Site, Burien, Washington, United States

Research Site, Wausau, Wisconsin, United States

Starting date: September 2003
Ending date: November 2007
Last updated: January 25, 2008