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

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ClinicalTrials.gov Identifier: NCT00214630
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: rosuvastatin calcium Drug: atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007



Intervention Details:
  • Drug: rosuvastatin calcium
    Other Name: Crestor
  • Drug: atorvastatin
    Other Name: Lipitor


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

Secondary Outcome Measures :
  1. % 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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214630


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00214630     History of Changes
Other Study ID Numbers: 4522US/0001
D3560L00021
LUNAR
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors