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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 21, 2005
Last updated: November 18, 2010
Last verified: November 2010
Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes

Condition Intervention Phase
Acute Coronary Syndromes
Drug: rosuvastatin calcium
Drug: atorvastatin
Phase 3

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Reduction of LDL-C following 12 weeks of treatment

Secondary Outcome Measures:
  • % 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

Enrollment: 825
Study Start Date: December 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rosuvastatin calcium
    Other Name: Crestor
    Drug: atorvastatin
    Other Name: Lipitor

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00214630

  Show 56 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00214630     History of Changes
Other Study ID Numbers: 4522US/0001  D3560L00021  LUNAR 
Study First Received: September 21, 2005
Last Updated: November 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2016