This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,438
LCZ696 200 mg tablet
Olmesartan 20 mg capsule
Placebo tablet of LCZ696 200 mg once daily
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg
Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement
Time frame: baseline, 8 weeks
Change From Baseline in Office Pulse Pressure (msPP)
Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.
Time frame: baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Blood Pressure
In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study.
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
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Placebo capsule of olmesartan 20 mg once daily
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Nanning, Guangxi, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
...and 40 more locations
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Time frame: baseline, 8 weeks
Number of Patients Achieving Successful Blood Pressure Control
Successful blood pressure control is defined as msSBP \<140 mmHg and msDBP \<90 mmHg.
Time frame: 8 weeks
Change From Baseline in Ambulatory Pulse Pressure
Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.
Time frame: baseline, 8 weeks
Number of Responders
Responders are patients with msSBP response (\<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (\<90 mmHg or ≥10 mmHg reduction from baseline)
Time frame: baseline, 8 weeks
Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Time frame: baseline, 8 weeks