Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
Condition: Moderate to Severe Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren/amlodipine 300/10 mg tablet; Amlodipine 10 mg capsule
Intervention description: Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.; Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
Intervention MeSH terms: Amlodipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; systolic blood pressure; cardiovascular disease; aliskiren; amlodipine

Summary:

      This study will compare the blood pressure (BP) lowering effect of the combination of
      aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate
      to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine
      produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP)
      after 8 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients ≥ 18 years of age

          -  Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160
             mmHg and < 200 mmHg at Visit 2

        Exclusion Criteria:

          -  Mild to moderate hypertension

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential

          -  Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class
             II-IV.

          -  Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.

          -  Uncontrolled Type 1 or Type 2 diabetes mellitus

          -  Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with
             Similar chemical structures

          -  History of hypertensive encephalopathy or cerebrovascular accident, or history of
             transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or
             any percutaneous coronary intervention

          -  Patients on a combination of 3 or more antihypertensive medications

        Other protocol-defined inclusion/exclusion criteria may apply