Hypertension
Conditions
Keywords
Hypertension, valsartan, LCZ696
Brief summary
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.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or females from 18 up to and including 75 years * Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs) * Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2). * Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP\> 95 mmHg at baseline (Visit 3);
Exclusion criteria
* Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg) * History of angioedema, drug-related or otherwise, as reported by the patient * Type 1 or Type 2 diabetes mellitus (according to the ADA criteria) * History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc. * History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | baseline, week 8 | Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | baseline, 8 weeks | 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. |
| Change From Baseline in Daytime maDBP and maSBP | baseline, 8 weeks | 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. |
| Change From Baseline in Nighttime maDBP and maSBP | baseline, 8 weeks | 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. |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | baseline, week 8 | Sitting BP measurements were performed at screening through the end of the study at every study visit. |
| Percentage of Participants Who Achieved a Successful Response in msSBP | 8 weeks | Successful response in msSBP is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline. |
| Percentage of Participants Who Achieved Successful Control in msDBP | 8 weeks | Successful control in msDBP is defined as msDBP \<90 mmHg. |
| Percentage of Participants Who Achieved Successful Control in msSBP | 8 weeks | Successful control in msSBP is defined as \<140 mmHg. |
| Percentage of Participants Who Achieved a Successful Response in msDBP | 8 weeks | Successful response in msDBP is defined as msDBP \<90 mmHg or a reduction ≥ 10 mmHg from baseline. |
Countries
Argentina, Canada, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Russia, Slovakia, Spain, Sweden, Taiwan, United States
Participant flow
Recruitment details
The study comprised 3 periods: a 4-week washout and placebo run-in period (pre-randomization), an 8-week randomized, double-blind monotherapy period, and 1-week randomized, placebo-controlled withdrawal period. In the randomized withdrawal, participants were either randomized to placebo or continued their original assigned treatment.
Pre-assignment details
After successful completion of the pre-randomization period, participants were randomized 1:1:1:1:1:1:1:1 ratio to one of 8 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| LCZ696 100 mg Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 156 |
| LCZ696 200 mg Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 169 |
| LCZ696 400 mg Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 172 |
| Valsartan 80 mg Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 163 |
| Valsartan 160 mg Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 166 |
| Valsartan 320 mg Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 164 |
| AHU377 200 mg Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. | 165 |
| Placebo Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 173 |
| Total | 1,328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Abnormal laboratory values | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Abnormal test procedure results | 0 | 0 | 0 | 2 | 0 | 1 | 1 | 1 |
| Overall Study | Administrative problems | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Adverse Event | 1 | 3 | 1 | 2 | 1 | 0 | 5 | 4 |
| Overall Study | Lack of Efficacy | 1 | 0 | 2 | 3 | 5 | 1 | 3 | 8 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 2 | 3 | 2 | 0 | 0 |
| Overall Study | Protocol deviation | 1 | 1 | 1 | 2 | 2 | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 4 | 5 | 6 | 6 | 4 | 9 |
Baseline characteristics
| Characteristic | LCZ696 100 mg | LCZ696 200 mg | LCZ696 400 mg | Valsartan 80 mg | Valsartan 160 mg | Valsartan 320 mg | AHU377 200 mg | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 10.4 | 54 years STANDARD_DEVIATION 9.7 | 52 years STANDARD_DEVIATION 10.9 | 53 years STANDARD_DEVIATION 9.6 | 53 years STANDARD_DEVIATION 9.7 | 53 years STANDARD_DEVIATION 10.1 | 53 years STANDARD_DEVIATION 10.7 | 54 years STANDARD_DEVIATION 10.6 | 53 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 61 Participants | 77 Participants | 75 Participants | 68 Participants | 68 Participants | 65 Participants | 75 Participants | 79 Participants | 568 Participants |
| Sex: Female, Male Male | 95 Participants | 92 Participants | 97 Participants | 95 Participants | 98 Participants | 99 Participants | 90 Participants | 94 Participants | 760 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 156 | 4 / 169 | 4 / 172 | 5 / 163 | 4 / 166 | 3 / 164 | 5 / 165 | 13 / 173 |
| serious Total, serious adverse events | 1 / 156 | 0 / 169 | 1 / 172 | 1 / 163 | 0 / 166 | 0 / 164 | 0 / 165 | 0 / 173 |
Outcome results
Primary
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
Population: Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LCZ696 100 mg | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -9.97 mmHg | Standard Error 0.73 |
| LCZ696 200 mg | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -12.92 mmHg | Standard Error 0.7 |
| LCZ696 400 mg | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -13.63 mmHg | Standard Error 0.7 |
| Valsartan 80 mg | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -9.14 mmHg | Standard Error 0.72 |
| Valsartan 160 mg | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -9.95 mmHg | Standard Error 0.71 |
| Valsartan 320 mg | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -10.93 mmHg | Standard Error 0.71 |
| AHU377 200 mg | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -9.76 mmHg | Standard Error 0.71 |
| Placebo | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -6.78 mmHg | Standard Error 0.69 |
Secondary
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
Population: Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 100 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -3.80 mmHg | Standard Error 0.72 |
| LCZ696 100 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -7.80 mmHg | Standard Error 1.04 |
| LCZ696 200 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -6.78 mmHg | Standard Error 0.64 |
| LCZ696 200 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -11.50 mmHg | Standard Error 0.93 |
| LCZ696 400 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -8.32 mmHg | Standard Error 0.71 |
| LCZ696 400 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -14.56 mmHg | Standard Error 1.03 |
| Valsartan 80 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -4.56 mmHg | Standard Error 0.67 |
| Valsartan 80 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -7.29 mmHg | Standard Error 0.96 |
| Valsartan 160 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -6.25 mmHg | Standard Error 0.7 |
| Valsartan 160 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -8.27 mmHg | Standard Error 1 |
| Valsartan 320 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -7.13 mmHg | Standard Error 0.67 |
| Valsartan 320 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -9.42 mmHg | Standard Error 0.97 |
| AHU377 200 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -5.18 mmHg | Standard Error 1.02 |
| AHU377 200 mg | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -3.67 mmHg | Standard Error 0.7 |
| Placebo | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maDBP | -1.33 mmHg | Standard Error 0.67 |
| Placebo | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | maSBP | -2.90 mmHg | Standard Error 0.96 |
Secondary
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
Population: Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 100 mg | Change From Baseline in Daytime maDBP and maSBP | maDBP | -4.05 mmHg | Standard Error 1.23 |
| LCZ696 100 mg | Change From Baseline in Daytime maDBP and maSBP | maSBP | -7.96 mmHg | Standard Error 1.73 |
| LCZ696 200 mg | Change From Baseline in Daytime maDBP and maSBP | maDBP | -6.91 mmHg | Standard Error 1.12 |
| LCZ696 200 mg | Change From Baseline in Daytime maDBP and maSBP | maSBP | -11.76 mmHg | Standard Error 1.58 |
| LCZ696 400 mg | Change From Baseline in Daytime maDBP and maSBP | maDBP | -7.80 mmHg | Standard Error 1.19 |
| LCZ696 400 mg | Change From Baseline in Daytime maDBP and maSBP | maSBP | -14.20 mmHg | Standard Error 1.67 |
| Valsartan 80 mg | Change From Baseline in Daytime maDBP and maSBP | maDBP | -4.78 mmHg | Standard Error 1.17 |
| Valsartan 80 mg | Change From Baseline in Daytime maDBP and maSBP | maSBP | -7.59 mmHg | Standard Error 1.65 |
| Valsartan 160 mg | Change From Baseline in Daytime maDBP and maSBP | maDBP | -7.40 mmHg | Standard Error 1.23 |
| Valsartan 160 mg | Change From Baseline in Daytime maDBP and maSBP | maSBP | -9.54 mmHg | Standard Error 1.73 |
| Valsartan 320 mg | Change From Baseline in Daytime maDBP and maSBP | maDBP | -7.47 mmHg | Standard Error 1.17 |
| Valsartan 320 mg | Change From Baseline in Daytime maDBP and maSBP | maSBP | -9.90 mmHg | Standard Error 1.66 |
| AHU377 200 mg | Change From Baseline in Daytime maDBP and maSBP | maSBP | -4.49 mmHg | Standard Error 1.72 |
| AHU377 200 mg | Change From Baseline in Daytime maDBP and maSBP | maDBP | -3.18 mmHg | Standard Error 1.22 |
| Placebo | Change From Baseline in Daytime maDBP and maSBP | maDBP | -1.53 mmHg | Standard Error 1.14 |
| Placebo | Change From Baseline in Daytime maDBP and maSBP | maSBP | -3.40 mmHg | Standard Error 1.61 |
Secondary
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
Population: Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LCZ696 100 mg | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -13.75 mmHg | Standard Error 1.15 |
| LCZ696 200 mg | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -18.70 mmHg | Standard Error 1.1 |
| LCZ696 400 mg | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -20.17 mmHg | Standard Error 1.1 |
| Valsartan 80 mg | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -12.44 mmHg | Standard Error 1.12 |
| Valsartan 160 mg | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -13.42 mmHg | Standard Error 1.12 |
| Valsartan 320 mg | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -14.16 mmHg | Standard Error 1.12 |
| AHU377 200 mg | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -11.93 mmHg | Standard Error 1.11 |
| Placebo | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -7.72 mmHg | Standard Error 1.09 |
Secondary
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
Population: Participants from the ABPM subset, who had both baseline nighttime and week 8 nighttime values, were included in the analysis only.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 100 mg | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -2.87 mmHg | Standard Error 1.25 |
| LCZ696 100 mg | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -6.40 mmHg | Standard Error 1.77 |
| LCZ696 200 mg | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -7.73 mmHg | Standard Error 1.13 |
| LCZ696 200 mg | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -11.85 mmHg | Standard Error 1.6 |
| LCZ696 400 mg | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -6.93 mmHg | Standard Error 1.23 |
| LCZ696 400 mg | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -12.04 mmHg | Standard Error 1.73 |
| Valsartan 80 mg | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -4.04 mmHg | Standard Error 1.17 |
| Valsartan 80 mg | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -6.43 mmHg | Standard Error 1.66 |
| Valsartan 160 mg | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -4.18 mmHg | Standard Error 1.24 |
| Valsartan 160 mg | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -5.82 mmHg | Standard Error 1.74 |
| Valsartan 320 mg | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -6.17 mmHg | Standard Error 1.18 |
| Valsartan 320 mg | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -7.51 mmHg | Standard Error 1.67 |
| AHU377 200 mg | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -3.99 mmHg | Standard Error 1.75 |
| AHU377 200 mg | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -3.31 mmHg | Standard Error 1.24 |
| Placebo | Change From Baseline in Nighttime maDBP and maSBP | maDBP | -1.01 mmHg | Standard Error 1.16 |
| Placebo | Change From Baseline in Nighttime maDBP and maSBP | maSBP | -2.09 mmHg | Standard Error 1.63 |
Secondary
Percentage 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
Population: Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCZ696 100 mg | Percentage of Participants Who Achieved a Successful Response in msDBP | 53.90 Percentage of participants |
| LCZ696 200 mg | Percentage of Participants Who Achieved a Successful Response in msDBP | 69.64 Percentage of participants |
| LCZ696 400 mg | Percentage of Participants Who Achieved a Successful Response in msDBP | 74.12 Percentage of participants |
| Valsartan 80 mg | Percentage of Participants Who Achieved a Successful Response in msDBP | 51.53 Percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved a Successful Response in msDBP | 55.83 Percentage of participants |
| Valsartan 320 mg | Percentage of Participants Who Achieved a Successful Response in msDBP | 63.19 Percentage of participants |
| AHU377 200 mg | Percentage of Participants Who Achieved a Successful Response in msDBP | 54.27 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a Successful Response in msDBP | 39.53 Percentage of participants |
Secondary
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
Population: Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCZ696 100 mg | Percentage of Participants Who Achieved a Successful Response in msSBP | 55.84 Percentage of participants |
| LCZ696 200 mg | Percentage of Participants Who Achieved a Successful Response in msSBP | 63.69 Percentage of participants |
| LCZ696 400 mg | Percentage of Participants Who Achieved a Successful Response in msSBP | 72.35 Percentage of participants |
| Valsartan 80 mg | Percentage of Participants Who Achieved a Successful Response in msSBP | 51.53 Percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved a Successful Response in msSBP | 51.53 Percentage of participants |
| Valsartan 320 mg | Percentage of Participants Who Achieved a Successful Response in msSBP | 57.06 Percentage of participants |
| AHU377 200 mg | Percentage of Participants Who Achieved a Successful Response in msSBP | 46.34 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved a Successful Response in msSBP | 37.79 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Successful Control in msDBP
Successful control in msDBP is defined as msDBP \<90 mmHg.
Time frame: 8 weeks
Population: Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCZ696 100 mg | Percentage of Participants Who Achieved Successful Control in msDBP | 47.40 Percentage of participants |
| LCZ696 200 mg | Percentage of Participants Who Achieved Successful Control in msDBP | 60.12 Percentage of participants |
| LCZ696 400 mg | Percentage of Participants Who Achieved Successful Control in msDBP | 65.88 Percentage of participants |
| Valsartan 80 mg | Percentage of Participants Who Achieved Successful Control in msDBP | 45.40 Percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Successful Control in msDBP | 47.85 Percentage of participants |
| Valsartan 320 mg | Percentage of Participants Who Achieved Successful Control in msDBP | 56.44 Percentage of participants |
| AHU377 200 mg | Percentage of Participants Who Achieved Successful Control in msDBP | 46.95 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved Successful Control in msDBP | 38.37 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Successful Control in msSBP
Successful control in msSBP is defined as \<140 mmHg.
Time frame: 8 weeks
Population: Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCZ696 100 mg | Percentage of Participants Who Achieved Successful Control in msSBP | 47.40 Percentage of participants |
| LCZ696 200 mg | Percentage of Participants Who Achieved Successful Control in msSBP | 56.55 Percentage of participants |
| LCZ696 400 mg | Percentage of Participants Who Achieved Successful Control in msSBP | 62.94 Percentage of participants |
| Valsartan 80 mg | Percentage of Participants Who Achieved Successful Control in msSBP | 45.40 Percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Successful Control in msSBP | 42.33 Percentage of participants |
| Valsartan 320 mg | Percentage of Participants Who Achieved Successful Control in msSBP | 53.37 Percentage of participants |
| AHU377 200 mg | Percentage of Participants Who Achieved Successful Control in msSBP | 37.20 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved Successful Control in msSBP | 31.98 Percentage of participants |