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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225589
First Posted: September 26, 2005
Last Update Posted: November 19, 2010
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.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225589


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Peters SA, Bots ML, Lind L, Groenewegen KA, de Korte C, den Ruijter HM; METEOR study group. The impact of variability in ultrasound settings on the measured echolucency of the carotid intima-media. J Hypertens. 2013 Sep;31(9):1861-7. doi: 10.1097/HJH.0b013e3283623548.
Lind L, Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Effect of rosuvastatin on the echolucency of the common carotid intima-media in low-risk individuals: the METEOR trial. J Am Soc Echocardiogr. 2012 Oct;25(10):1120-1127.e1. doi: 10.1016/j.echo.2012.07.004. Epub 2012 Aug 9.
Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Biologically implausible carotid intima-media thickness measurement values: effects on rate of change over time. Curr Med Res Opin. 2012 Jun;28(6):891-9. doi: 10.1185/03007995.2012.689255. Epub 2012 Jun 6.
Stein EA, Vidt DG, Shepherd J, Cain VA, Anzalone D, Cressman MD. Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program. Atherosclerosis. 2012 Apr;221(2):471-7. doi: 10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.
Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Lind L, Bots ML; METEOR Study Group. Manual or semi-automated edge detection of the maximal far wall common carotid intima-media thickness: a direct comparison. J Intern Med. 2012 Mar;271(3):247-56. doi: 10.1111/j.1365-2796.2011.02422.x. Epub 2011 Aug 11.
Peters SA, Dogan S, Meijer R, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML. The use of plaque score measurements to assess changes in atherosclerotic plaque burden induced by lipid-lowering therapy over time: the METEOR study. J Atheroscler Thromb. 2011;18(9):784-95. Epub 2011 May 27.
Peters SA, Palmer MK, Grobbee DE, Crouse JR 3rd, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Effect of number of ultrasound examinations on the assessment of carotid intima-media thickness changes over time: the example of the METEOR study. J Hypertens. 2011 Jun;29(6):1145-54. doi: 10.1097/HJH.0b013e328345d85e.
Peters SA, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Raichlen JS, Bots ML. C-reactive protein lowering with rosuvastatin in the METEOR study. J Intern Med. 2010 Aug;268(2):155-61. doi: 10.1111/j.1365-2796.2010.02230.x. Epub 2010 Mar 6.
Bots ML, Palmer MK, Dogan S, Plantinga Y, Raichlen JS, Evans GW, O'Leary DH, Grobbee DE, Crouse JR 3rd; METEOR Study Group. Intensive lipid lowering may reduce progression of carotid atherosclerosis within 12 months of treatment: the METEOR study. J Intern Med. 2009 Jun;265(6):698-707. doi: 10.1111/j.1365-2796.2009.02073.x. Epub 2009 Mar 2.
Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007 Mar 28;297(12):1344-53. Epub 2007 Mar 25.
Crouse JR 3rd, Grobbee DE, O'Leary DH, Bots ML, Evans GW, Palmer MK, Riley WA, Raichlen JS; METEOR Study Group. Carotid intima-media thickness in low-risk individuals with asymptomatic atherosclerosis: baseline data from the METEOR study. Curr Med Res Opin. 2007 Mar;23(3):641-8.

ClinicalTrials.gov Identifier: NCT00225589     History of Changes
Other Study ID Numbers: 4522IL/0088
METEOR
D3562C00088 ( Other Identifier: AstraZeneca )
First Submitted: September 22, 2005
First Posted: September 26, 2005
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Hypercholesteremia

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


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