telmisartan with or without hydrochlorothiazide (hctz) compared with losartan with or without hctz in mild to moderate hypertensive patients

Conditions: Hypertension

Summary: study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (dbp) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (abpm - ambulatory blood pressure measurement). secondary objectives: changes from baseline in bp at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and abpm safety: incidence of adverse events (ae's); withdrawal due to adverse events; laboratory parameters


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (dbp) ≥ 95 mmhg and \< 110 mmhg and systolic blood pressure (sbp) \< 180 mmhg measured by manual cuff sphygmomanometer at the end of the wash-out period * written informed consent exclusion criteria: * nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation \> 1 year prior to start wash-out phase or surgically sterile * secondary hypertension * malignant hypertension (retinal haemorrhage, exudates or papillary oedema) * clinically significant sodium depletion as defined by serum sodium level \ 5.5 meq/l or clinically significant hypokaliemia as defined by serum potassium level \< 3.0 meq/l * atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial * congestive heart failure (chf) (nyha (new york heart association) functional class chf iii-iv) * angina pectoris or myocardial infarction * cardiac surgery within the past 3 months prior to start the wash-out period * stroke within the past 6 months prior to start the wash-out period * renal insufficiency defined as creatininaemia \> 2mg/dl * bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant, presence of only one functioning kidney * liver insufficiency, defined as bilirubinaemia \> 2mg/dl and ast (aspartate aminotransferase) or alt (alanine-aminotransferase) \> twice the upper normal range * clinically significant metabolic and endocrine disease * autoimmune disease * previous history of angioedema * body mass index \> 30kg/m2 * arm circumference \> 32 cm * any condition that may be likely to compromise patients participation to the trial (alcohol or drug abuse, disability illness, etc.) * concomitant therapy with antihypertensive drugs non permitted by protocol, corticosteroids or drugs known to affect blood pressure * concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hctz) * investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial * sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, losartan, hctz) * predictable lack of patient co-operation