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

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.