The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
588
10 mg, 20 mg, 40 mg capsules
Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
100 mg, 200 mg tablets
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.
Time frame: Baseline, 4 weeks, 14 weeks
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
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Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Suzhou, Jiangsu, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Xi’an, Shanxi, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China
...and 69 more locations
Time frame: Baseline, 10 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.
Time frame: Baseline, 4 weeks, 10 weeks, 14 weeks
Change From Baseline in Daytime and Nighttime maSBP/maDBP
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg.
Time frame: 4 weeks, 10 weeks, 14 weeks
Number of Participants Achieving Successful Response in msSBP and msDBP
Blood pressure response in msSBP was defined as a mean sitting BP \< 140 mmHg or a \>=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or \>=10 mmHg reduction from baseline.
Time frame: 4 weeks,10 weeks, 14 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Adverse event monitoring was conducted throughout the study.
Time frame: 14 weeks