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

Hypercholesteremia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225589
• Other study ID #: 4522IL/0088
• Secondary ID: METEORD3562C0008
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2005
• Last updated: November 18, 2010
• Start date: August 2002
• Est. completion date: May 2006

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin calcium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Finland,  France,  Germany,  Netherlands,  Norway, 

Outcome

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