This study is a phase 2 study in patients with essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
389
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
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 Mean Sitting Systolic Blood Pressure (msSBP)
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 24 Hour Mean Ambulatory DBP and SBP
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Daytime Mean Ambulatory DBP and SBP
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Nighttime Mean Ambulatory DBP and SBP
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. A negative change from baseline indicates improvement.
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Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Chongqing, China
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Shimotsuke, Tochigi, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
...and 24 more locations
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Mean sitting pulse pressure is the difference in msSBP and msDBP (msSBP - msDBP). A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Ambulatory Pulse Pressure
Mean ambulatory pulse pressure is the difference in maSBP and maDBP (maSBP - maDBP). A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Number of Participants Who Achieved a Successful Response in msDBP
Successful response in msDBP is defined as msDBP \<90 mmHg or a reduction ≥ 10 mmHg from baseline.
Time frame: 8 weeks
Number of Participants Who Achieved a Successful Response in msSBP
Successful response in msSBP is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline.
Time frame: 8 weeks
Number of Participants Who Achieved Successful BP Control
BP control is defined as BP \< 140/90 mmHg.
Time frame: 8 weeks
Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP
Trough to post-dosing hour ratio at each post-dosing hour = \[trough LSM of LCZ696 - trough LSM of placebo\]/\[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo\]
Time frame: baseline, 8 weeks
Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP
Trough to post-dosing hour ratio at each post-dosing hour = \[trough LSM of LCZ696 - trough LSM of placebo\]/\[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo\]
Time frame: baseline, 8 weeks
Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8
From week 8 to week 9, participants entered a single-blind placebo withdrawal period to assess the effect of LCZ696 on blood pressure following its discontinuation. Participants, who were randomized to the LCZ696 treatment groups, were discontinued from CLCZ696 at the end of week 8 and all 4 treatment groups received single-blind placebo for 1 week post week 8. A positive change from week 8 to week 9 indicates worsening.
Time frame: 8 weeks, 9 weeks