A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to
 placebo for treating Chinese patients with subclinical atherosclerosis.
This study is a randomized, double-blind, placebo-controlled, multicenter parallel group
 study assessing the effects of rosuvastatin 20 mg treatment for 104 weeks on the change in
 intimamedia thickness (IMT) of the common carotid artery (CCA), carotid bulb, and internal
 carotid artery (ICA) in adult Chinese subjects with subclinical atherosclerosis.
Inclusion Criteria:

 -  Provision of informed consent prior to any study-specific procedures

 -  Male aged ≥45 and <70 years or female aged ≥55 and <70 years

 -  Subjects with only hypertension (as defined blood pressure ≥140/90 mmHg or on
 antihypertensive treatment) and age as CVD risk factors and subjects without
 hypertension who have 3 or more other risk factors (including age) must have "Fasting
 LDL C of ≥120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1mmol/L)"; Subjects without
 hypertension who have fewer than 3 other risk factors (including age) must have
 "Fasting LDL-C of ≥120 mg/dL (3.1 mmol/L) and <190 mg/dL (4.9 mmol/L)"

 -  Triglycerides <500 mg/dL (5.65 mmol/L) at Visit 1

 -  HDL-C levels ≤60 mg/dL (1.6 mmol/L) at Visit 1

 -  Maximum IMT ≥1.2 mm and <3.5 mm at any location in the carotid ultrasound scans
 conducted at both Visit 2 and Visit 3

 -  Willing to follow all study procedures including study visits, fasting blood draws,
 and compliance with study treatment regimen

 Exclusion Criteria:

 -  Use of pharmacologic lipid-lowering medications (eg, statins, fibrate derivatives,bile
 acid binding resins, niacin, or its analogues at doses >400 mg or prescribed Chinese
 traditional drugs), including cholesterol-absorption inhibitors (CAIs), and CAI/statin
 combination, within 12 months prior to Visit 1

 -  Current or recent (within 2 weeks of Visit 1) use of supplements known to alter lipid
 metabolism (eg, soluble fibers [including >2 teaspoons Metamucil® or
 psyllium-containing supplement per day] or other dietary fiber supplements, marine
 oils, sterol/stanol products, or other supplement determined at the discretion of the
 investigator)

 -  History of hypersensitivity reactions to other HMG-CoA reductase inhibitors

 -  Pregnant women, women who are breast-feeding, and women of childbearing potential who
 are not using chemical or mechanical contraception or who have a positive serum
 pregnancy test

 -  Clinical evidence of coronary artery disease (CAD) or any other atherosclerotic
 disease such as angina, MI, transient ischemic attack, symptomatic CAD,
 cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass
 graft, peripheral arterial disease, abdominal aortic aneurysm

 -  History of cancer (other than basal cell carcinoma) in the past 2 years

 -  Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of
 ≥110 mmHg or a resting systolic blood pressure of ≥180 mmHg recorded at any time
 during the screening period

 -  History of diabetes mellitus or current diabetes mellitus

 -  Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) >1.5 times
 the upper limit of normal (ULN) at Visit 1 or subjects whose thyroid replacement
 therapy was initiated within the last 3 months

 -  History of heterozygous or homozygous familial hypercholesterolemia or known
 hyperlipoproteinemia Types I, III, IV, or V (familial dysbetalipoproteinemia)

 -  Use of the disallowed concomitant medications within 12 months prior to Visit 1

 -  History of alcohol and/or drug abuse within the past 5 years

 -  Active liver disease or hepatic dysfunction as defined by elevations of ≥1.5 x ULN at
 Visit 1 in any of the following liver function tests: ALT, AST or bilirubin

 -  Serum creatine kinase (CK) >3 x ULN at Visit 1

 -  Serum creatinine >2.0 mg/dL (177 mmol/L) recorded during the screening period

 -  Participation in another investigational drug study, and having ingested
 investigational drug ≤4 weeks before enrollment in the screening period

 -  Previous randomization in the present study

 -  History of a significant medical or psychological condition that, in the opinion of
 the investigator, would compromise the subject's safety or successful participation in
 the study

 -  Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
 staff and/or staff at the study site)