bp-ease -effectiveness of losartan 50 mg/hydrochlorothiazide (hctz) 12.5 mg versus valsartan 80 mg/hctz 12.5 mg titrated as needed in patients with essential hypertension not controlled on monotherapy (0954a-333)

Conditions: Hypertension

Summary: to evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.


Eligibility criteria:
inclusion criteria: * an adult patient 18 to 75 years of age * patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled: * either systolic or diastolic blood pressure \> 140/90 mm hg up to 180/110 mm hg (inclusive) * either systolic or diastolic blood pressure \> 130/80 mm hg up to 160/100 mm hg (inclusive) for diabetic patients * patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below: * surgically sterilized female * postmenopausal female \> 45 years of age with \> 2 years since her last menses * non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy \[either 2 barrier methods or a barrier method plus a hormonal method\]; or (2) abstain from heterosexual activity throughout the study starting with visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with visit 1 and for 14 days after the last dose of study medication * patient judged to be in otherwise good, stable health on the basis of medical history and physical examination exclusion criteria: * known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy) * patient needing an initiation of a lipid lowering agent or a modification of his lipid therapy at visit 1 or during the study period (12 weeks) * patient taking allopurinol * patient previously shown to be intolerant to any component of losartan valsartan, or hctz or with a documented history of angioedema/anaphylaxis * patient with confirmed clinically significant renal or hepatic dysfunction and/or electrolyte imbalance laboratory test within the last 3 months prior to visit 1: serum creatinine \> 130 umol/l or creatinine clearance \ 2 times above the normal range, alanine transaminase (alt) \> 2 times above the normal range, serum potassium \ 5.5 meq/l * patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months * patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents * patient with symptomatic heart failure (classes 3 and 4) * patient with a history of stroke within the last 6 months * patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina * patient having participated in an investigational drug program in the last 30 days (prior to visit 1) * unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion * patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.