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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:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date November 19, 2010
Study Start Date  ICMJE December 2003
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
Reduction of LDL-C following 12 weeks of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
% 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
Official Title  ICMJE 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
Brief Summary Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndromes
Intervention  ICMJE
  • Drug: rosuvastatin calcium
    Other Name: Crestor
  • Drug: atorvastatin
    Other Name: Lipitor
Study Arms  ICMJE Not Provided
Publications * Pitt B, Loscalzo J, Ycas J, Raichlen JS. Lipid levels after acute coronary syndromes. J Am Coll Cardiol. 2008 Apr 15;51(15):1440-5. doi: 10.1016/j.jacc.2007.11.075.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2008)
825
Original Enrollment  ICMJE
 (submitted: September 21, 2005)
828
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Costa Rica,   El Salvador,   Morocco,   Panama,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00214630
Other Study ID Numbers  ICMJE 4522US/0001
D3560L00021
LUNAR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP