Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

Inclusion Criteria:

• Outpatients ≥18 years of age.

• Patients with a diagnosis of Stage II hypertension, defined as mean sitting SystolicBlood Pressure (msSBP) ≥ 160 mmHg and < 180 mmHg at Visit 2.

Exclusion Criteria:

• Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic BloodPressure (msDBP) ≥ 110 mmHg.

• Secondary form of hypertension.

• Current diagnosis of heart failure (New York Heart Association [NYHA] Class II-IV).

• Current angina pectoris requiring pharmacological therapy (other than stable doses oforal or topical nitrates).

• Second or third degree heart block without a pacemaker.

• Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrialfibrillation or atrial flutter, during the 12 months prior to Visit 1.

• Clinically significant valvular heart disease.

• Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack (TIA), heart attack, coronary bypass surgery or any PCI.

• Known Keith-Wagener grade III or IV hypertensive retinopathy.

• In the month prior to Visit 1, patients on combination antihypertensive therapy thatincludes more than 2 classes of antihypertensive medications.

• Patients on combined antihypertensive medication that contain two classes ofantihypertensive medications are considered to take two antihypertensive medications.

• Inability to discontinue prior antihypertensive or other CV medications as required bythe protocol.

• Patients with Type 1 diabetes mellitus.

• Patients with Type 2 diabetes mellitus not well controlled .

• Elevated Serum potassium (over 5.3 mEq/L (mmol/L).

• Any surgical or medical condition or the use of any medication which mightsignificantly alter the absorption, distribution, metabolism, or excretion of studydrugs. Other protocol-defined inclusion/exclusion criteria may apply.