This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,161
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
Olmesartan 20 mg capsule one daily
Placebo to LCZ696 or Olmesartan
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8
Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
Time frame: Baseline, 8 weeks
Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8
A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg.
Time frame: 8 weeks
Percentage of Participants Achieving a Successful msSBP Response
Successful msSBP response was defined as \< 140 mmHg or ≥ 20 mmHg reduction from baseline.
Time frame: 8 weeks
Percentage of Participants Achieving a Successful msDBP Response
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Novartis Investigative Site
Kamogawa, Chiba, Japan
Novartis Investigative Site
Chikushi-gun, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Asahikawa, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
...and 51 more locations
Successfull msDBP response was defined as \<90 mmHg or ≥10 mmHg reduction from baseline.
Time frame: 8 weeks
Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time frame: Baseline, 8 weeks
Change From Baseline in maSBP and maDBP for Daytime/Nighttime
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time frame: Baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure
Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.
Time frame: Baseline, 8 weeks
Number of Patients With Adverse Events, Serious Adverse Events and Death
Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Time frame: 8 weeks