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

November 18, 2010 updated by: AstraZeneca

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

Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

825

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
      • San Jose, Costa Rica
        • Research Site
  • El Salvador
      • San Salvador, El Salvador
        • Research Site
  • Morocco
      • Ayer, Morocco
        • Research Site
  • Panama
      • Panama City, Panama
        • Research Site
  • United States
    • California
      • San Diego, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, United States
        • Research Site
    • Florida
      • Atlantis, Florida, United States
        • Research Site
      • Brandon, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Pensacola, Florida, United States
        • Research Site
      • Safety Harbor, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
    • Illinois
      • Aurora, Illinois, United States
        • Research Site
      • Chicago, Illinois, United States
        • Research Site
      • Lombard, Illinois, United States
        • Research Site
      • Melrose Park, Illinois, United States
        • Research Site
      • Peoria, Illinois, United States
        • Research Site
    • Indiana
      • Anderson, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
      • Owensboro, Kentucky, United States
        • Research Site
    • Louisiana
      • Covington, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States
        • Research Site
      • Towson, Maryland, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Pontiac, Michigan, United States
        • Research Site
      • Troy, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
      • St. Paul, Minnesota, United States
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Kalispell, Montana, United States
        • Research Site
    • New Jersey
      • Newark, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Fairview Park, Ohio, United States
        • Research Site
      • Springfield, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
      • Tulsa, Oklahoma, United States
        • Research Site
    • Oregon
      • Bend, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Amarillo, Texas, United States
        • Research Site
      • Beaumont, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States
        • Research Site
    • Washington
      • Burien, Washington, United States
        • Research Site
    • Wisconsin
      • Wausau, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of LDL-C following 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
% 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Crestor Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4522US/0001
  • D3560L00021
  • LUNAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndromes

Clinical Trials on atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe