Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

Exclusion Criteria

• •Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
• •Patients on 4 or more antihypertensive medications.
• •Patients with uncontrolled hypertension (MSSBP \>180 mmHg) taking more than 1 antihypertensive medication at Visit 1
• •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 (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
• •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• •Evidence of a secondary form of hypertension, including but not limited to any of the following:
• •* coarctation of the aorta
• •* hyperaldosteronism
• •* unilateral or bilateral renal artery stenosis
• •* Cushing's disease
• •* polycystic kidney disease
• •* pheochromocytoma
• •Known Keith-Wagener grade III or IV hypertensive retinopathy.
• •History of angioedema due to usage of an ARB or ACE inhibitor.
• •History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months