This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
564
Investigative Site
Houston, Texas, United States
Investigative Site
Belgium, Belgium
Investigative Site
Egypt, Egypt
Investigative Site
Germany, Germany
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: 54 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.
Time frame: Baseline, Weeks 28 and 54 endpoint
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.
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Investigative Site
Poland, Poland
Investigative Site
Slovakia, Slovakia
Investigative Site
Spain, Spain
Investigative Site
Turkey, Turkey (Türkiye)
Time frame: Baseline, Weeks 28 and 54 endpoints
Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg
Blood pressure control was defined as having a mean sitting diastolic blood pressure \<90 mmHg and a mean sitting systolic blood pressure \<140 mmHg. Percentage of participants achieving the blood pressure control of \< 140/90 mmHg were reported. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28 and Week 54 Endpoint was the last non-missing measurement value after Week 28.
Time frame: Weeks 28 and 54 endpoints
Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure
Diastolic Blood pressure response was defined as a mean sitting diastolic blood pressure \<90 mmHg or a \>=10 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.
Time frame: Weeks 28 and 54 endpoints
Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure
Systolic blood pressure response was defined as a mean sitting systolic blood pressure \<140 mmHg or a \>=20 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.
Time frame: Weeks 28 and 54 endpoints