This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
756
Placebo tablet taken once daily in the morning with a light meal.
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
Investigative Site
Buenos Aires, Argentina
Investigative Site
Prague, Czechia
Investigative Site
Berlin, Germany
Investigative Site
Reykjavik, Iceland
Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving Systolic Blood Pressure Response
Patients achieving a systolic blood pressure response had to have a msSBP \< 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.
Time frame: Baseline to end of study (Week 8)
Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study
Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.
Time frame: Baseline to end of study (Week 8)
Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.
Time frame: Baseline to end of study (Week 8)
Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
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Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
Investigative Site
Rome, Italy
Investigative Site
Amsterdam, Netherlands
Investigative Site
Warsaw, Poland
Investigative Site
Bratislava, Slovakia
The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.
Time frame: Baseline to end of study (week 8)