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

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 becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
• •Pregnant or nursing (lactating) women
• •History of malignancy of any organ system within the past five years
• •Any severe, life-threatening disease within the past five years
• •History of drug or alcohol abuse within the last 2 years.