To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

A Single Center, Randomized, Double-blind, Active Controlled, Parallel Group Study to Demonstrate Non-inferiority of a Fixed Dose Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan in the Treatment of Hypertension

The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.

Inclusion Criteria:

• Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
• High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score >10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.

Exclusion Criteria:

• Known or suspected secondary hypertension
• Known New York Heart Association (NYHA) functional class IV Heart Failure
• History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
• Clinically significant valvular disease
• Women who are pregnant, intend to become pregnant or are breastfeeding
• Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
• Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
• Other protocol-defined inclusion/exclusion criteria may apply