the confirmatory olmesartan plaque regression study

Conditions: Essential Hypertension; Carotid Plaque

Summary: effect of olmesartan medoxomil (20-40 mg) on plaque regression in hypertensive patients with carotid atherosclerosis.


Eligibility criteria:
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 \ 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 \[including renovascular occlusive disease, nephrectomy and/or renal transplant, creatinine clearance of \ 300 mg albumin/24 hours or 300 µg albumin/mg creatinine)\]. * 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.