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

This study has been completed.

First Received: September 21, 2005 Last Updated: March 25, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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:

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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:	August 2007

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

Show 56 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Crestor Medical Science Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	4522US/0001, D3560L00021, LUNAR
Study First Received:	September 21, 2005
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00214630 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Acute Coronary Syndrome
Cardiovascular Diseases
Atorvastatin

ClinicalTrials.gov processed this record on March 18, 2010