Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

• Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. [ Time Frame: 24 weeks ]
  For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.
• Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] [ Time Frame: Baseline and Week 24 ]
• Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] [ Time Frame: 24 weeks ]
  Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).
• Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment [ Time Frame: 24 weeks ]

• Percentage of patients reaching BP target [ Time Frame: 24 weks ]
• BP-lowering effect, msSBP/msDBP responder rate and control rates based on treatment algorithm [ Time Frame: 24 weeks ]
• Responder rate for msSBP and for msDBP [ Time Frame: 24 weeks ]
• Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment [ Time Frame: 24 weeks ]

• Drug: Aliskiren
  Aliskiren 150 or 300 mg
• Drug: Hydrochlorothiazide
  Hydrochlorothiazide 12.5 or 25 mg
• Drug: Amlodipine
  Amlodipine 5 or 10 mg

Inclusion Criteria:

• Outpatients ≥ 18 years of age
• Patients with a diagnosis of mild to moderate hypertension at Visit 1
• All patients must have a msSBP ≥ 140 mmHg and < 180 mmHg and/or msDBP ≥ 90 mmHg and < 110 mmHg mmHg at Visit 3

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria may apply.