Phase
Condition
High Blood Pressure (Hypertension)
Vascular Diseases
Diabetes And Hypertension
Treatment
Comparator: Valsartan (+) Hydrochlorothiazide
losartan potassium (+) hydrochlorothiazide
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
An Adult Patient 18 to 75 Years Of Age
Patient with essential hypertension receiving an antihypertensive agent inmonotherapy 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 oneof 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 methodsof contraception to prevent pregnancy [either 2 barrier methods or a barriermethod plus a hormonal method]; or (2) abstain from heterosexual activitythroughout the study starting with Visit 1 and for 14 days after the last doseof study medication; or (3) only engage in heterosexual activity withsurgically 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 medicalhistory and physical examination
Exclusion
Exclusion Criteria:
Known secondary hypertension of any aetiology (e.g., uncorrected renal arterystenosis, malignant hypertension, or hypertensive encephalopathy)
Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of HisLipid 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, OrHCTZ Or With A Documented History Of Angioedema/Anaphylaxis
Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/OrElectrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1:Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartatetransaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
Patient with osteoarthritis who has undergone hip or knee replacement within thelast 4 months
Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus,inflammatory bowel disease and those that need a chronic inflammatory therapy suchas 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 coronaryangioplasty, has had coronary artery bypass, has had past myocardial infarction, allthat 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 trialbefore its completion
Patient intends to move or to vacation away from home during the course of the studywhich would interfere with the scheduled visits.