Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

Inclusion Criteria:

• 18 aged or over

• Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg ifon anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not onanti-hypertensive drugs

• Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg

Exclusion Criteria:

• Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3to 7 days

• ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from thereference arm selected at Screening

• History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers orthiazide diuretics

• Secondary hypertension or suspected to be

• Continuously took medicinal drugs that might affect blood pressure rather thananti-hypertensive drugs more than 3 months

• Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus

• History of severe neurovascular disease, severe heart disease

• Known as moderate or malignant retinopathy.

• Renal diseases; serum creatinine ≥ 2mg/dl

• Hepatic diseases; increase in ALT or AST ≥ 2xUNL

• Anuria

• Hyponatremia/hypokalemia or hypercalcemia

• Active Gout

• Surgical or medical diseases which might significantly change ADME of medicines

• History of malignant tumor

• Autoimmune diseases

• History of alcohol or drug abuse

• Positive to pregnancy test, nursing mother, woman with an intention of pregnancy

• Considered inappropriate to participate in the clinical trial with any reason, basedon investigator's decision Other protocol-defined inclusion/exclusion criteria may apply