Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren/Amlodipine; Amlodipine
Intervention description: Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg; Amlodipine 5 mg titrated to 10mg
Intervention MeSH terms: Amlodipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 443.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; African Americans; Aliskiren; Amlodipine; Systolic blood pressure; Diastolic blood pressure; Stage II; Combination

Summary:

      The purpose of the study is to evaluate the BP-lowering efficacy of the combination of
      aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African
      American patients with Stage II hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women of African American background; self identified

          -  Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and < 200 mmHg at Visit
             5 (randomization

        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

        Other protocol defined inclusion/exclusion criteria applied