Intervention: Rosuvastatin
Trial phase: Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 272
Group description: Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
Eligibility criteria:
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)