HypercholesteremiaPhase 3NCT00225589
A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)
A Phase 3 study testing Rosuvastatin calcium in people with Hypercholesteremia, run by AstraZeneca at 57 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Hypercholesteremia
- What is being tested?
- Rosuvastatin calcium
- How many people
- 840 participants
- Where
- 57 sitesin 8 countries
- Study dates
- Aug 2002to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
57 sites in 8 countries.
57 sites in 8 countries
France21 sites
Research Site
Auboué
Research Site
Bagnolet
Research Site
Boulogne-Billancourt
Research Site
Briey
Research Site
Delme
Research Site
Drancy
Research Site
Fresnes-en-Woëvre
Research Site
Ivry-sur-Seine
Research Site
Jarny
Research Site
Les Lilas
Research Site
Marange-Silvange
Research Site
Mars-la-Tour
Research Site
Metz
Research Site
Meudon
Research Site
Montigny-lès-Metz
Research Site
Moûtiers
Research Site
Paris
Research Site
Saint-Germain-en-Laye
Research Site
Thionville
Research Site
Yerres
Research Site
Yutz
United States20 sites
Research Site
Alhambra, California
Research Site
Boston, Massachusetts
Research Site
Brooklyn Center, Minnesota
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Glen Mills, Pennsylvania
Research Site
Houston, Texas
Research Site
Kirkland, Washington
Research Site
La Jolla, California
Research Site
Los Angeles, California
Research Site
Madison, Wisconsin
Research Site
Minneapolis, Minnesota
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Renton, Washington
Research Site
Salisbury, North Carolina
Research Site
San Diego, California
Research Site
Santa Ana, California
Research Site
Seattle, Washington
Research Site
Winston-Salem, North Carolina
Germany4 sites
Research Site
Essen, North Rhine-Westphalia
Research Site
Essen
Research Site
München, Bavaria
Research Site
München
Belgium3 sites
Research Site
Brussels
Research Site
Brussels (Anderlecht)
Research Site
Leuven
Netherlands3 sites
Research Site
Amsterdam
Research Site
Rotterdam
Research Site
Utrecht
Norway3 sites
Research Site
Bekkestua
Research Site
Oslo
Research Site
Skedsmokorset
About this study
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)
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.
- Conditions
- Hypercholesteremia
- Being tested
- Rosuvastatin calcium
- Keywords
- Hypercholesteremia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin calciumDrug
Also called Crestor
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HypercholesteremiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 840 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Crestor Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225589
- Sponsor's protocol ID
- 4522IL/0088
- Other IDs
- METEOR, D3562C00088
- Status last verified
- Nov 2010
- First submitted
- 22 Sep 2005
- Last updated
- 19 Nov 2010
- Results posted
- No
Publications
Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
PubMed 37565307Peters 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.
PubMed 23868083Lind 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.
PubMed 22884641Peters 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.
PubMed 22536884Stein 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.
PubMed 22304793Peters 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.
PubMed 21726301Peters 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. doi: 10.5551/jat.8169. Epub 2011 May 27.
PubMed 21617330Peters 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.
PubMed 21546878Peters 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.
PubMed 20412373Bots 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.
PubMed 19298496Crouse 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. doi: 10.1001/jama.297.12.1344. Epub 2007 Mar 25.
PubMed 17384434Crouse 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. doi: 10.1185/030079907X178711.
PubMed 17355745
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00225589
- Acronym / sponsor ID
- 4522IL/0088
- Conditions
- Hypercholesteremia
- Keywords
- Hypercholesteremia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin calciumAlso: Crestor | Drug | – |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
- Derived from this study: PubMed 37565307Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
- Derived from this study: PubMed 23868083Peters 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.
- Derived from this study: PubMed 22884641Lind 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.
- Derived from this study: PubMed 22536884Peters 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.
- Derived from this study: PubMed 22304793Stein 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.
- Derived from this study: PubMed 21726301Peters 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.
- Derived from this study: PubMed 21617330Peters 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. doi: 10.5551/jat.8169. Epub 2011 May 27.
- Derived from this study: PubMed 21546878Peters 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.
- Derived from this study: PubMed 20412373Peters 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.
- Derived from this study: PubMed 19298496Bots 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.
- Derived from this study: PubMed 17384434Crouse 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. doi: 10.1001/jama.297.12.1344. Epub 2007 Mar 25.
- Derived from this study: PubMed 17355745Crouse 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. doi: 10.1185/030079907X178711.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Crestor Medical Science Director, MD study director
AstraZeneca
57 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin calcium in people with Hypercholesteremia, run by AstraZeneca at 57 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in France, United States, Germany, Belgium, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00225589, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.