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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
443
Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine 5 mg titrated to 10mg
Investigative Site
Chicago, Illinois, United States
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Oxon Hill, Maryland, United States
Investigative Site
Detroit, Michigan, United States
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).
Time frame: Baseline, 8 weeks
Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)
Cumulative percentage of patients achieving BP control (\<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Time frame: 8 weeks
Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)
Cumulative percentage of responders (Responders are defined as patients with MSSBP \<140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Time frame: 8 weeks
Change From Baseline in MSSBP at Week 1 and 4
Compare the change from baseline in MSSBP at week 1 and 4
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Investigative Site
Trenton, New Jersey, United States
Investigative Site
Brooklyn, New York, United States
Investigative Site
Springfield Gardens, New York, United States
Investigative Site
Philadelphia, Pennsylvania, United States
Investigative Site
Milwaukeee, Wisconsin, United States
Time frame: Baseline, 1 and 4 weeks
Percentage of Patients With Peripheral Edema by Visit
Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.
Time frame: 8 weeks