This study will compare the efficacy and safety of once daily dosing of aliskiren
monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in
patients with Stage II hypertension over a period of 12 weeks.
- Outpatients ≥18 years of age.
- Patients with a diagnosis of Stage II hypertension, defined as msSBP ≥ 160 mmHg and <
180 mmHg at Visit 2.
- Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg.
- Secondary form of hypertension.
- Current diagnosis of heart failure (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, 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
Other protocol-defined inclusion/exclusion criteria may apply.