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LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
This study has been completed.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00214630
  Purpose

Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes


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

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium Calcium gluconate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

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: September 2003
Study Completion Date: November 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214630

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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
  More Information

Publications indexed to this study:
Study ID Numbers: 4522US/0001, D3560L00021, LUNAR
Study First Received: September 21, 2005
Last Updated: January 25, 2008
ClinicalTrials.gov Identifier: NCT00214630  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Calcium, Dietary
Rosuvastatin
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Ischemia
Atorvastatin

Additional relevant MeSH terms:
Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Syndrome
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009