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A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 22, 2005
Last updated: November 18, 2010
Last verified: November 2010
The purpose of this trial is to see if rosuvastatin will be effective in decreasing the thickness of the walls of the arteries in the neck for people who already have some evidence of thickening of these walls.

Condition Intervention Phase
Hypercholesteremia Drug: Rosuvastatin calcium Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase III Study Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA

Secondary Outcome Measures:
  • Assess the effects of rosuvastatin treatment on the following variables, with the same analyses being applied to the IMT variables:
  • Change in the mean maximum IMT of the near & far walls of the right & left CCA, carotid bulb, ICA
  • Change in the mean IMT of the near & far walls of the right & left CCA
  • Change in LDL-C, TC, HDL-C, TG, nonHDL-C, ApoB, ApoA-I, nonHDL-C/HDL-C, & ApoB/ApoA-I
  • Change in inflammatory marker: C-reactive protein (CRP)
  • Safety & tolerability, by evaluating the incidence & severity of adverse events & abnormal laboratory values

Estimated Enrollment: 840
Study Start Date: August 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosuvastatin calcium
    Other Name: Crestor

Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Maximum IMT >1.2 mm and 3.5 mm at any location in the carotid ultrasound studies conducted at both Visit 2 (Week -4) and Visit 3 (Week -2)
  • Subjects with age and no other risk factor: Fasting LDL-C at Visit 1 (Week -6) is >120 mg/dL (3.1mmol/L) and <190 mg/dL (4.9 mmol/L)
  • Subjects with 2 or more risk factors and a 10-year coronary heart disease (CHD) risk < 10%: Fasting LDL-C at Visit 1 (Week -6) is >120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1 mmol/L)

Exclusion Criteria:

  • Use of pharmacologic lipid-lowering medications (eg, HMG-CoA reductase inhibitors, fibrate derivatives, bile acid binding resins, niacin or its analogues at doses >400 mg) within 12 months prior to Visit 1 (Week -6).
  • Clinical evidence of coronary artery disease or any other atherosclerotic disease such as angina, MI, TIA, symptomatic carotid artery disease, CVA, CABG, PTCA, peripheral arterial disease, AAA.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00225589

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United States, California
Research Site
Alhambra, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
United States, Illinois
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Brooklyn Center, Minnesota, United States
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Minneapolis, Minnesota, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Glen Mills, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Kirkland, Washington, United States
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Renton, Washington, United States
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Seattle, Washington, United States
United States, Wisconsin
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Madison, Wisconsin, United States
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Brussels (Anderlecht), Belgium
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Brussels, Belgium
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Leuven, Belgium
Czech Republic
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Praha 2, Czech Republic
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Slaný, Czech Republic
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Kuopio, Finland
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Auboue, France
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Bagnolet, France
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Boulogne Billancourt, France
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Briey, France
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Delme, France
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Drancy, France
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Fresnes En Woevre, France
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Ivry Sur Seine, France
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Jarny, France
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Les Lilas, France
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Marange Silvange, France
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Mars La Tour, France
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Metz, France
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Meudon, France
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Montigny Les Metz, France
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Moutiers, France
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Paris cedex 14, France
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Paris, France
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St Germain En Laye, France
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Thionville, France
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Yerres, France
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Yutz, France
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München, Bayern, Germany
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Essen, Nordrhein-Westfalen, Germany
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Essen, Germany
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München, Germany
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Amsterdam, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Bekkestua, Norway
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Oslo, Norway
Research Site
Skedsmokorset, Norway
Sponsors and Collaborators
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00225589     History of Changes
Other Study ID Numbers: 4522IL/0088
D3562C00088 ( Other Identifier: AstraZeneca )
Study First Received: September 22, 2005
Last Updated: November 18, 2010

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on July 21, 2017