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

Acute Coronary Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214630
• Other study ID #: 4522US/0001
• Secondary ID: D3560L00021LUNAR
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2005
• Last updated: November 18, 2010
• Start date: December 2003
• Est. completion date: August 2007

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 825
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

Intervention

Drug:
• rosuvastatin calcium

• atorvastatin

Locations

Country	Name	City	State
Costa Rica	Research Site	San Jose
El Salvador	Research Site	San Salvador
Morocco	Research Site	Ayer
Panama	Research Site	Panama City
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Amarillo	Texas
United States	Research Site	Anderson	Indiana
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Annapolis	Maryland
United States	Research Site	Asheville	North Carolina
United States	Research Site	Atlantis	Florida
United States	Research Site	Aurora	Illinois
United States	Research Site	Beaumont	Texas
United States	Research Site	Bend	Oregon
United States	Research Site	Brandon	Florida
United States	Research Site	Bridgeport	Connecticut
United States	Research Site	Burien	Washington
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Covington	Louisiana
United States	Research Site	Dallas	Texas
United States	Research Site	Danville	Pennsylvania
United States	Research Site	Des Moines	Iowa
United States	Research Site	Fairview Park	Ohio
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalispell	Montana
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lombard	Illinois
United States	Research Site	Louisville	Kentucky
United States	Research Site	Lubbock	Texas
United States	Research Site	Melrose Park	Illinois
United States	Research Site	Memphis	Tennessee
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Newark	New Jersey
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Owensboro	Kentucky
United States	Research Site	Pensacola	Florida
United States	Research Site	Peoria	Illinois
United States	Research Site	Pontiac	Michigan
United States	Research Site	Portland	Oregon
United States	Research Site	Rochester	New York
United States	Research Site	Safety Harbor	Florida
United States	Research Site	San Diego	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Springfield	Ohio
United States	Research Site	St. Louis	Missouri
United States	Research Site	St. Paul	Minnesota
United States	Research Site	Tampa	Florida
United States	Research Site	Torrance	California
United States	Research Site	Towson	Maryland
United States	Research Site	Troy	Michigan
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Wausau	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Costa Rica,  El Salvador,  Morocco,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of LDL-C following 12 weeks of treatment
Secondary	% 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