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

Condition(s) targeted: Hypercholesteremia

Intervention: Rosuvastatin calcium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Crestor Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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)

Study design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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

Minimum age: 45 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Research Site, Brussels, Belgium

Research Site, Brussels (Anderlecht), Belgium

Research Site, Leuven, Belgium

Research Site, Praha 2, Czech Republic

Research Site, Slaný, Czech Republic

Research Site, Kuopio, Finland

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, France

Research Site, Essen, Germany

Research Site, München, Germany

Research Site, Amsterdam, Netherlands

Research Site, ROTTERDAM, Netherlands

Research Site, UTRECHT, Netherlands

Research Site, BEKKESTUA, Norway

Research Site, Oslo, Norway

Research Site, SKEDSMOKORSET, Norway

Research Site, München, Bayern, Germany

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

Research Site, Chicago, Illinois, United States

Research Site, Boston, Massachusetts, United States

Research Site, Brooklyn Center, Minnesota, United States

Research Site, Minneapolis, Minnesota, United States

Research Site, Essen, Nordrhein-Westfalen, Germany

Research Site, Salisbury, North Carolina, United States

Research Site, Winston-Salem, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Glen Mills, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Houston, Texas, United States

Research Site, Kirkland, Washington, United States

Research Site, Renton, Washington, United States

Research Site, Seattle, Washington, United States

Research Site, Madison, Wisconsin, United States

Starting date: August 2002
Last updated: August 22, 2006