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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00214630
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : August 2007
Study Completion Date : August 2007


Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Contacts and Locations

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
More Information

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