efficacy and safety of valsartan/amlodipine compared to amlodipine in patients with essential hypertension

Conditions: Essential Hypertension

Summary: this study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure \[mssbp\] ≥ 130 mmhg and ≤ 160 mmhg) on amlodipine 5 mg alone. the study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.


Eligibility criteria:
inclusion criteria: * male or female outpatients ≥ 55 years of age * patients with essential hypertension measured using a validated automated oscillometric device at visit 1 * non-treated patients must have a mssbp ≥ 140 mmhg and ≤ 160 mmhg * patients pre-treated on monotherapy prior to visit 1 must have mssbp ≤ 160 mmhg * to be eligible for randomization at visit 2 (day 1) all patients must have a mssbp ≥ 130 mmhg and ≤ 160 mmhg * no peripheral edema at visit 2 (randomization) * written informed consent to participate in this study prior to any study procedures exclusion criteria: * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant * known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures * patients taking more than 1 antihypertensive medication at visit 1 * administration of any agent indicated for the treatment of hypertension after visit 1 with the exception of pre-treated patients that require tapering down of anti-hypertensive treatments. for patients with previous antihypertensive medication that require a gradual downward titration, the tapering down should be done according to manufacturers instructions and last dose should be taken by week -2 prior to randomization * mssbp \> 180 mmhg or msdbp \> 110 mmhg at any time between visit 1 and visit 2 * evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing's disease, polycystic kidney disease, or pheochromocytoma * history of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (pci) or coronary artery bypass graft surgery (cabg) 12 months prior to visit 1 * history of heart failure grade ii - iv according to the nyha classification * second or third degree heart block with or without a pacemaker * concomitant potentially life threatening arrhythmia or symptomatic arrhythmia * concomitant unstable angina pectoris * clinically significant valvular heart disease * patients with type 1 diabetes mellitus * patients with type 2 diabetes mellitus who are not well controlled based on the investigator's judgment. it is recommended that type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to visit 1 * evidence of hepatic disease as determined by one of the following: ast or alt values \> 2x unl at study entry, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt * evidence of renal impairment as determined by one of the following: serum creatinine \> 1.5 x unl at visit 1, history of dialysis, or history of nephrotic syndrome * serum potassium values \> 5.5 mmol/l at study entry * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug * any surgical or medical condition which, at the discretion of the investigator or novartis medical monitor, places the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study period * volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values * any severe, life-threatening disease within the past five years * history of drug or alcohol abuse within the last 2 years * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer * inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent * persons directly involved in the execution of this protocol

Keywords: essential hypertension blood pressure edema valsartan amlodipine combination treatment