Status:
COMPLETED
A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)
Lead Sponsor:
AstraZeneca
Conditions:
Hypercholesteremia
Eligibility:
All Genders
45-70 years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT00225589
Start Date
August 1 2002
End Date
May 1 2006
Last Update
November 19 2010
Active Locations (57)
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1
Research Site
Alhambra, California, United States
2
Research Site
La Jolla, California, United States
3
Research Site
Los Angeles, California, United States
4
Research Site
San Diego, California, United States