This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
376
Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
Time frame: baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Time frame: baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.
Time frame: baseline, 8 weeks
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Fair Oaks, California, United States
Novartis Investigative Site
Hawaiian Gardens, California, United States
Novartis Investigative Site
Long Beach, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Orangevale, California, United States
Novartis Investigative Site
Westlake Village, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Conyers, Georgia, United States
...and 41 more locations
Number of Patients Achieving Successful Overall Blood Pressure Control
Successful overall blood pressure control is defined as both msSBP/msDBP \<140/90 mmHg
Time frame: 8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
Successful mean sitting systolic blood pressure control is defined as msSBP \<140 mmHg
Time frame: 8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
Successful mean sitting diastolic blood pressure control is defined as msDBP \<90 mmHg
Time frame: 8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
Successful mean sitting systolic blood pressure response is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline.
Time frame: baseline, 8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
Successful mean sitting diastolic blood pressure response is defined as msDBP \<90 mmHg or a reduction ≥10 mmHg from baseline.
Time frame: baseline, 8 weeks
Number of Patients With Total Adverse Events, Serious Adverse Events and Death
Number of patients with total adverse events, serious adverse events and death were reported.
Time frame: 8 weeks