The Confirmatory Olmesartan Plaque Regression Study (CONFIRM)

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.