Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension (AIMS)

Inclusion Criteria:

• Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
• Male or female outpatients ≥ 18 years old.
• Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and <200 mmHg at Study Visit 5 (randomization).

• Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:

  • Abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
  • Current triglycerides ≥ 150 mg/dL or medical treatment for this condition.
  • Current HDL- Cholesterol <40 mg/dL in men and <50 mg/dL in women or medical treatment for this condition.
  • Fasting glucose >100 mg/dL and <126 mg/dL

Exclusion Criteria:

• Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
• History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
• History or evidence of secondary form of hypertension.
• Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
• Patients on 4 or more antihypertensive medications.