This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,334
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, week 8
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.
Time frame: baseline, week 8
Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP
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.
Time frame: baseline, 8 weeks
Change From Baseline in Daytime maDBP and maSBP
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae 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.
Time frame: baseline, 8 weeks
Change From Baseline in Nighttime maDBP and maSBP
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.
Time frame: baseline, 8 weeks
Percentage of Participants Who Achieved a Successful Response in msDBP
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Muscle Shoals, Alabama, United States
Novartis Investigative Site
Chandler, Arizona, United States
Novartis Investigative Site
Buena Park, California, United States
Novartis Investigative Site
Fair Oaks, 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
Santa Ana, California, United States
Novartis Investigative Site
Stockton, California, United States
...and 172 more locations
Successful response in msDBP is defined as msDBP \<90 mmHg or a reduction ≥ 10 mmHg from baseline.
Time frame: 8 weeks
Percentage 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
Percentage of Participants Who Achieved Successful Control in msDBP
Successful control in msDBP is defined as msDBP \<90 mmHg.
Time frame: 8 weeks
Percentage of Participants Who Achieved Successful Control in msSBP
Successful control in msSBP is defined as \<140 mmHg.
Time frame: 8 weeks