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)

AstraZeneca55 sites in 7 countries840 target enrollmentStarted: August 1, 2002Last updated: November 19, 2010

Conditions

Drugs

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: AstraZeneca
Enrollment: 840
Locations: 55
Primary Endpoint: 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

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Masking: Double

Eligibility Criteria

Ages: 45 Years to 70 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor

AstraZeneca

Sponsor Class

Industry

Study Sites (55)

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