The Confirmatory Olmesartan Plaque Regression Study

Inclusion Criteria: * Male and female Caucasian outpatients aged \> 40 years. * High BP defined as mean SeSBP/SeDBP ≥ 140/90 mmHg. * One or more of the following additional risk factors: * Smoking; * Dyslipidaemia (high-density lipoprotein (HDL)-cholesterol \< 0.9 mmol/L or low-density lipoprotein (LDL)-cholesterol \> 2.6 mmol/L, or triglycerides \> 1.7 mmol/L); * Left ventricular hypertrophy; * Cardio-cerebrovascular events \> 6 months ago; * Presence of target organ damage. * Non-calcified (not marked shadowing) plaque in the CC artery, in the internal carotid artery or the carotid bulb with a PV ≥ 0.040 cm³ (≥ 40 µL) according to the measurements of EUTARC. Exclusion Criteria: * Secondary or high grade hypertension including grade III hypertension (SeSBP of \> 180 mmHg or SeDBP of \> 105 mmHg). * Stroke, myocardial infarction within the previous 6 months. * Interventional or surgical vascular treatment within the previous 3 months. * Presence of significant narrowing of the aortic or bicuspid valve and severe obstruction of cardiac outflow (hypertrophic cardiomyopathy). * Symptomatic heart failure. * Diabetes. * Chronic obstructive pulmonary disease (COPD) or asthma. * Claudication intermittens stage II b or higher. * Clinical evidence of severe renal disease \[including renovascular occlusive disease, nephrectomy and/or renal transplant, creatinine clearance of \< 30 mL/min, macroalbuminuria (\> 300 mg albumin/24 hours or 300 µg albumin/mg creatinine)\]. * Treatment with angiotensin converting enzyme (ACE)-inhibitors or angiotensin-receptor blockers (ARBs) during last 3 months. * Start of treatment with a lipid-lowering agent or modification of dosage within last 3 months. * Electrocardiographic (ECG) evidence of 2nd or 3rd degree atrioventricular (AV) block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia (\< 50 beats/min at rest). * Known intolerance to study drugs. * Impaired liver function tests suggesting severe liver disorder. * Any life threatening disease. * Duplex sonographically determined stenosis of the common or internal carotid artery \> 75%. * Plaque with marked shadowing from calcification. * Target plaques in CC artery extending into both internal and external arteries. * Pregnant or lactating female subjects. * Female subjects of childbearing potential without adequate contraception: intra-uterine devices, hormonal contraceptives, either oral, depot, patch or injectable and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. If a female becomes pregnant during the trial, she has to be withdrawn immediately (see section 9.4). * Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents. * Subject has previously entered this study. * Subjects who have received ATE within 30 days prior to entering the active treatment phase. * Subjects who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period. * Subjects with history of alcohol and or drug abuse. * Subjects with known malabsorption syndrome. * Subjects who had donated or lost 450 mL or more blood during the last three months before Screening.