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

Phase 3

Completed

• Conditions: Hypercholesteremia

• Registration Number: NCT00225589
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-26
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Change in the mean IMT of the near & far walls of the right & left CCA
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
Safety & tolerability, by evaluating the incidence & severity of adverse events & abnormal laboratory values

Trial Locations

Locations (1)

Research Site; 🇳🇴 Skedsmokorset, Norway