safety and efficacy study of a triple combination therapy in subjects with hypertension

Conditions: Hypertension

Summary: to determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.


Eligibility criteria:
inclusion criteria: * demonstrable hypertension defined as mean sitting trough cuff blood pressure ≥ 140/100 mmhg (sesbp ≥ 140 mmhg and sedbp ≥ 100mmhg) or mean sitting trough cuff bp ≥ 160/90 mmhg (sesbp ≥ 160 mmhg and sedbp ≥ 90mmhg). * male or female newly diagnosed hypertensive subjects or currently on hypertension medication. * negative urine pregnancy test at screening * not lactating * do not plan to become pregnant during the study * will practice birth control throughout the study by the following: oral or patch contraceptive, injectable or implantable contraceptive medication, intrauterine device, diaphragm or female condom plus spermicide * non childbearing potential must be classified by one of the following criteria * had a hysterectomy or tubal ligation at least 6 months prior to consent * has been postmenopausal for a least 1 year exclusion criteria: * mean sitting trough cuff dbp \<90 mmhg or mean sitting trough cuff sbp \<140 mmhg (off antihypertensive medication). * subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator). * signs or symptoms which could exacerbate the occurrence of hypotension such as volume and salt depletion. * history of hypertensive encephalopathy, stroke or transient ischemic attack (tia). * participation in another clinical trial involving an investigational drug within one month prior to screening. * history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina within the past 6 months. * any history of new york heart association class iii or iv congestive heart failure (chf). a history of new york heart association class i or ii chf may be exclusionary at the discretion of the investigator. * history of secondary hypertension including renal disease, pheochromocytoma, or cushing's syndrome. * uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a solitary kidney. * evidence of symptomatic resting bradycardia. * evidence of hemodynamically significant cardiac valvular disease. * presence of heart block greater than first degree atrioventricular block, chronic atrial fibrillation or flutter. * uncontrolled type i or type ii diabetes defined as hba1c \>9.0%. diabetics must have documentation of hba1c within 6 months of the screening visit. undocumented subjects must have their hba1c assessed prior to randomization. note: subjects with type i or type ii diabetes controlled with insulin, diet or oral hypoglycemic agents on a stable dose for at least 30 days may be included. * evidence of liver disease as indicated by alt and ast and/or total bilirubin \>3 times the upper limit of normal. * severe renal insufficiency defined as a creatinine clearance (based on the cockcroft-gault formula) of \<30 ml/min. * clinically significant laboratory elevations at visit 1 that compromise subject safety, based on the investigator's judgment. consideration should take into account the potential laboratory effects of the component blinded therapies. * positive for any one of the following tests: hepatitis b surface antigen, hepatitis c antibody (confirmed by radio immunobinding assay, riba) or hiv antibody (confirmed by western blot assay). * subjects with malignancy during the past 2 years excluding squamous cell or basal cell carcinoma of the skin. * known allergy to any of the medications used in the study. * subjects who require or are taking any concomitant medication, which may interfere with the objectives of the study (refer to section 5.2 for a listing of excluded medications). * pregnant or lactating females. * current history of drug or alcohol abuse. * a subject with any medical condition, which in the judgment of the investigator would jeopardize the evaluation of efficacy or safety and/or constitute a significant safety risk to the subject.