Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension

Inclusion criteria

• Male or female patients ≥18 years of age
• Patients treated with up to two high blood pressure medications in a stable dose considered adequate by the investigator, for a minimum of two months, with blood pressure not controlled according to the following criteria:
• Systolic Blood Pressure ≥140 mmHg and/or Diastolic Blood Pressure ≥90 mmHg for low risk patients (no known target organ damage and without risk factor or presenting 1 - except Type 2 diabetes mellitus - risk factor);
• Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥85 mmHg for medium risk patients (no known target organ damage and 2 or more risk factors - except Type 2 diabetes mellitus);
• Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥80 mmHg for high risk patients (known target organ damage, and/or Type 2 diabetic patients and/or any clinically identifiable cardiovascular disease). OR
• Systolic Blood Pressure ≥160 mmHg and/or Diastolic Blood Pressure ≥100 mmHg at Visits 1 and 2 for previously untreated patients
• Patients previously treated but who stopped their medications will be considered untreated after one month without treatment
• Obs: -The target organ are: Brain, Heart, Kidney, Retina.
• The risk factors are: Smoking, Dyslipidemia, Age > 60 years old, and Family history of cardiovascular diseases (women < 65 years old and men < 55 years old

Exclusion criteria

• Systolic Blood Pressure ≥180 mmHg and/or Diastolic Blood Pressure ≥110 mmHg at Visit 1 or Visit 2
• Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma
• Known Keith-Wagener grade III or IV hypertensive retinopathy
• History of hypertensive encephalopathy
• Cerebrovascular accident or myocardial infarction 12 months prior to Visit 1
• History of transient ischemic attack 12 months prior to Visit 1
• Percutaneous coronary intervention or coronary artery bypass graft surgery 12 months prior to Visit 1
• Diabetes mellitus type 1
• Diabetes mellitus type 2 under insulin treatment
• Poorly controlled type 2 diabetes mellitus
• History of heart failure Grade II - IV according to the NYHA classification
• Second or third degree heart block without a pacemaker
• Concomitant unstable angina pectoris
• Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
• Clinically significant valvular heart disease
• Women of child-bearing potential
• Pregnant or nursing (lactating) women
• Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
• Additional protocol-defined inclusion/exclusion criteria may apply