Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

Inclusion Criteria:

• Male or female

• 18 years of age or older

• msDBP and msSBP requirements:

• 3A:

• Diagnosis of moderate to severe hypertension (msSBP ≥ 160 mmHg and < 200mmHg, and/or msDBP ≥ 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit)

• In addition, at the visit immediately prior to the above qualifying visit,patients were also to have msSBP ≥ 145 mmHg and < 200 mmHg and msDBP ≥ 95mmHg and < 120 mmHg) at Visits 3, 5 or 5.

• Patients had to meet the above two sets of requirements at subsequentadjacent visits, i.e. either Visits 3 and 4, Visits 4 and 5, or Visits 5 and

• OR

• 3B:

• msSBP ≥ 180 mmHg and < 200 mmHg with msDBP ≥ 95 mmHg and < 120 mmHg, ormsDBP ≥ 110 mmHg and < 120 mmHg with msSBP ≥ 150 mmHg and < 200 mmHg afterat least one week of treatment with placebo (Visit 3 and on).

Exclusion Criteria:

• Continued use of anti-hypertensive medicines or use of 4 or more hypertensivemedicines at study start

• Patients with an msSBP ≥ 200 mmHg or msDBP ≥ 120 mmHg at any time during the placeborun-in period were to be discontinued from the study.

• Extremely elevated (defined) blood pressure at any point during the study

• Pregnant or lactating women

• Pre-menopausal women not taking accepted form of birth control

• History or evidence of secondary form of hypertension

• History of cardiovascular conditions Other protocol-defined inclusion/exclusion criteria applied to the study.