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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00225589
First received: September 22, 2005
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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
Endpoint Classification: Efficacy Study
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
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225589

  Hide Study Locations
Locations
United States, California
Research Site
Alhambra, California, United States
Research Site
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
United States, Massachusetts
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Boston, Massachusetts, United States
United States, Minnesota
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Brooklyn Center, Minnesota, United States
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Minneapolis, Minnesota, United States
United States, North Carolina
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, Pennsylvania
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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
United States, Texas
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Houston, Texas, United States
United States, Washington
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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
Belgium
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Brussels, Belgium
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Brussels (Anderlecht), Belgium
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Leuven, Belgium
Czech Republic
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Praha 2, Czech Republic
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Slaný, Czech Republic
Finland
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Kuopio, Finland
France
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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, France
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Paris cedex 14, 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
Germany
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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
Netherlands
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Amsterdam, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
Norway
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Bekkestua, Norway
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Oslo, Norway
Research Site
Skedsmokorset, Norway
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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00225589     History of Changes
Other Study ID Numbers: 4522IL/0088, METEOR, D3562C00088
Study First Received: September 22, 2005
Last Updated: November 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Hypercholesteremia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014