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

Inclusion Criteria:

• Outpatients ≥18 years of age.
• Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic Blood Pressure (msSBP) ≥ 160 mmHg and < 180 mmHg at Visit 2.

Exclusion Criteria:

• Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood Pressure (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 of oral or topical nitrates).
• Second or third degree heart block without a pacemaker.
• Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation 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 that includes more than 2 classes of antihypertensive medications.
• Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
• Inability to discontinue prior antihypertensive or other CV medications as required by the 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 might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

Other protocol-defined inclusion/exclusion criteria may apply.