8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

• Change from baseline (visit 3) in mean 24 hour ambulatory diastolic blood pressure (maDBP) to week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
  24 hour ambulatory blood pressure measurement (ABPM) twice at beginning and end of 8 weeks
• Proportion of patients achieving blood pressure control [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  Patients achieving blood pressure control, which is defined as mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg, will be compared between treatment groups at Week 8 endpoint
• Change from baseline (visit 3) in trough mean sitting blood pressure to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  Change from baseline (visit 3) in trough msSBP and msDBP to week 8
• Pharmacokinetic of Aliskiren: The observed maximum plasma concentration (Cmax) following drug administration [mass/volume] in fasted vs. fed [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: No ]
  Pharmacokinetic assessment of effect of light meal on aliskiren drug absorption and systemic exposure
• Pharmacokinetic of Aliskiren: The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau (AUCtau) in fasted vs. fed [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: No ]
  Pharmacokinetic assessment of effect of light meal on aliskiren drug absorption and systemic exposure
• Pharmacokinetic of Aliskiren: time to reach the maximum concentration (Tmax) after drug administration in fasted vs. fed [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: No ]
  Pharmacokinetic assessment of effect of light meal on aliskiren drug absorption and systemic exposure
• Change-from baseline of plasma renin activity (PRA) at each timepoint in the biomarker subset [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  Plasma renin activity change from baseline to visit 6 (week 8).

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.

• Experimental: Aliskiren 300mg: Fed
  Aliskiren 300 mg once daily
  Intervention: Drug: Aliskiren
• Experimental: Aliskiren 300: Fasting
  Aliskiren 300 mg once daily without a light meal (fasted)
  Intervention: Drug: Aliskiren

Inclusion Criteria:

• Male or female outpatients age ≥ 18 years old. A higher age limit will be considered for countries based on their local regulations ( e.g., Taiwan, ≥ 20 years)

  • Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
  • Patients must have an office BP ≥ 140/90 mmHg and < 180/110mmHg at the randomization visit and the preceding visit
  • Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and their msDBP between the randomization visit and the preceding visit

Exclusion Criteria:

• Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ≥180 mmHg or msDBP ≥110 mmHg)
• History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD).
• Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 8%
• Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of aliskiren, including but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active, or active inflammatory bowel syndrome within 12 months prior to Visit 1, regarded as clinically meaningful by the investigator.

Other protocol-defined inclusion/exclusion criteria may apply.

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