Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension

Inclusion Criteria: * 18 years of age or older. * Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg. Exclusion Criteria: * History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics * Inability to stop all prior blood pressure medications safely * Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg * Controlled blood pressure (systolic BP \< 140 mmHg) taking more than 3 antihypertensive medications at screening * Systolic BP ≥ 140 mmHg and \< 180 mmHg taking more than two antihypertensive medications at screening * Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening * History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina * Type 1 diabetes * Poorly controlled Type 2 diabetes * History of heart failure * Arrhythmia * Significant valvular heart disease * Active gout * History of autoimmune diseases * History of multiple drug allergies * Liver disease * Pancreatic injury within 1 year of screening * Evidence of kidney impairment or history of dialysis * Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction. * Women of child-bearing potential (WOCBP), defined as all women physiologically capable of…