Trial Outcomes & Findings for Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension (NCT NCT01785472)
NCT ID: NCT01785472
Last Updated: 2016-12-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1438 participants
Primary outcome timeframe
baseline, 8 weeks
Results posted on
2016-12-29
Participant Flow
Participant milestones
| Measure |
LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
LCZ696 400 mg
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
|
Olmesartan 20 mg
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
479
|
473
|
486
|
|
Overall Study
Full Analysis Set (FAS)
|
479
|
472
|
484
|
|
Overall Study
Safety Set (SAF)
|
478
|
472
|
484
|
|
Overall Study
COMPLETED
|
455
|
454
|
464
|
|
Overall Study
NOT COMPLETED
|
24
|
19
|
22
|
Reasons for withdrawal
| Measure |
LCZ696 200 mg
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
LCZ696 400 mg
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
|
Olmesartan 20 mg
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
Protocol deviation
|
0
|
2
|
2
|
|
Overall Study
Subject/guardian decision
|
15
|
10
|
11
|
|
Overall Study
Technical problems
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension
Baseline characteristics by cohort
| Measure |
LCZ696 200 mg
n=479 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
LCZ696 400 mg
n=472 Participants
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
|
Olmesartan 20 mg
n=484 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Total
n=1435 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.5 Years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 9.71 • n=7 Participants
|
57.4 Years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
57.7 Years
STANDARD_DEVIATION 10.01 • n=4 Participants
|
|
Gender
Female
|
227 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
679 Participants
n=4 Participants
|
|
Gender
Male
|
252 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
756 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 8 weeksPopulation: Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments
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.
Outcome measures
| Measure |
LCZ696 200 mg
n=477 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=479 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
|
-20.48 mmHg
Standard Error 0.61
|
-18.15 mmHg
Standard Error 0.61
|
—
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments
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
Outcome measures
| Measure |
LCZ696 200 mg
n=469 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=479 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg
|
-21.67 mmHg
Standard Error 0.62
|
-18.15 mmHg
Standard Error 0.61
|
—
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and week 8 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement
Outcome measures
| Measure |
LCZ696 200 mg
n=477 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=469 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=479 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg
|
-8.10 mmHg
Standard Error 0.37
|
-8.80 mmHg
Standard Error 0.38
|
-6.86 mmHg
Standard Error 0.37
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and endpoint were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments
Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.
Outcome measures
| Measure |
LCZ696 200 mg
n=477 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=469 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=479 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Change From Baseline in Office Pulse Pressure (msPP)
|
-12.35 mmHg
Standard Error 0.42
|
-12.93 mmHg
Standard Error 0.43
|
-11.25 mmHg
Standard Error 0.42
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed
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.
Outcome measures
| Measure |
LCZ696 200 mg
n=188 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=184 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=182 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Blood Pressure
maSBP
|
-12.07 mmHg
Standard Error 0.49
|
-12.76 mmHg
Standard Error 0.49
|
-10.26 mmHg
Standard Error 0.49
|
|
Change From Baseline in Mean 24-hour Ambulatory Blood Pressure
maDBP
|
-6.36 mmHg
Standard Error 0.31
|
-6.82 mmHg
Standard Error 0.31
|
-5.61 mmHg
Standard Error 0.31
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed
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
Outcome measures
| Measure |
LCZ696 200 mg
n=55 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=79 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=74 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 16
|
-4.92 mmHg
Standard Deviation 14.788
|
-12.82 mmHg
Standard Deviation 13.386
|
-4.40 mmHg
Standard Deviation 15.974
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 18
|
-9.84 mmHg
Standard Deviation 15.789
|
-11.70 mmHg
Standard Deviation 13.799
|
-8.90 mmHg
Standard Deviation 14.907
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 23
|
-9.23 mmHg
Standard Deviation 20.068
|
-16.63 mmHg
Standard Deviation 15.752
|
-14.09 mmHg
Standard Deviation 25.454
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 24
|
-8.43 mmHg
Standard Deviation 15.330
|
-15.76 mmHg
Standard Deviation 17.392
|
-12.71 mmHg
Standard Deviation 15.199
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 1
|
-13.22 mmHg
Standard Deviation 16.506
|
-15.02 mmHg
Standard Deviation 14.578
|
-9.07 mmHg
Standard Deviation 17.597
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 2
|
-17.24 mmHg
Standard Deviation 20.423
|
-18.11 mmHg
Standard Deviation 15.343
|
-13.95 mmHg
Standard Deviation 19.247
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 3
|
-14.99 mmHg
Standard Deviation 19.378
|
-16.83 mmHg
Standard Deviation 16.312
|
-14.51 mmHg
Standard Deviation 18.436
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 4
|
-13.09 mmHg
Standard Deviation 19.460
|
-16.37 mmHg
Standard Deviation 18.710
|
-14.63 mmHg
Standard Deviation 18.824
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 5
|
-11.19 mmHg
Standard Deviation 19.376
|
-18.88 mmHg
Standard Deviation 16.636
|
-14.64 mmHg
Standard Deviation 21.177
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 6
|
-13.66 mmHg
Standard Deviation 16.785
|
-19.19 mmHg
Standard Deviation 17.771
|
-11.54 mmHg
Standard Deviation 21.885
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 7
|
-11.74 mmHg
Standard Deviation 21.552
|
-18.07 mmHg
Standard Deviation 19.748
|
-11.74 mmHg
Standard Deviation 24.674
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 8
|
-13.84 mmHg
Standard Deviation 17.365
|
-16.12 mmHg
Standard Deviation 16.696
|
-12.99 mmHg
Standard Deviation 20.555
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 9
|
-16.33 mmHg
Standard Deviation 16.437
|
-15.64 mmHg
Standard Deviation 18.915
|
-13.33 mmHg
Standard Deviation 18.360
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 10
|
-13.81 mmHg
Standard Deviation 17.670
|
15.13 mmHg
Standard Deviation 18.014
|
-10.89 mmHg
Standard Deviation 19.814
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 11
|
-12.98 mmHg
Standard Deviation 16.856
|
-15.93 mmHg
Standard Deviation 19.022
|
-7.66 mmHg
Standard Deviation 18.816
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 12
|
-8.99 mmHg
Standard Deviation 17.913
|
-15.54 mmHg
Standard Deviation 20.397
|
-10.51 mmHg
Standard Deviation 19.516
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 13
|
-12.46 mmHg
Standard Deviation 18.694
|
-13.28 mmHg
Standard Deviation 17.014
|
-11.49 mmHg
Standard Deviation 18.587
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 14
|
-9.64 mmHg
Standard Deviation 17.001
|
-12.33 mmHg
Standard Deviation 16.449
|
-6.66 mmHg
Standard Deviation 17.906
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 15
|
-7.73 mmHg
Standard Deviation 17.362
|
-10.12 mmHg
Standard Deviation 14.433
|
-7.81 mmHg
Standard Deviation 15.383
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 17
|
-10.20 mmHg
Standard Deviation 15.780
|
-12.43 mmHg
Standard Deviation 14.397
|
-7.19 mmHg
Standard Deviation 14.937
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 19
|
-8.94 mmHg
Standard Deviation 12.283
|
-12.20 mmHg
Standard Deviation 15.012
|
-5.76 mmHg
Standard Deviation 16.029
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 20
|
-8.03 mmHg
Standard Deviation 19.411
|
-15.04 mmHg
Standard Deviation 14.647
|
-4.83 mmHg
Standard Deviation 15.953
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 21
|
-9.47 mmHg
Standard Deviation 16.984
|
-14.33 mmHg
Standard Deviation 13.585
|
-9.97 mmHg
Standard Deviation 16.552
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hour 22
|
-12.62 mmHg
Standard Deviation 17.527
|
-17.20 mmHg
Standard Deviation 14.304
|
-9.95 mmHg
Standard Deviation 18.490
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed
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
Outcome measures
| Measure |
LCZ696 200 mg
n=55 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=79 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=74 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 13
|
-6.84 mmHg
Standard Deviation 12.616
|
-6.33 mmHg
Standard Deviation 10.802
|
-6.69 mmHg
Standard Deviation 14.822
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 23
|
-6.12 mmHg
Standard Deviation 13.266
|
-9.95 mmHg
Standard Deviation 10.374
|
-9.89 mmHg
Standard Deviation 15.553
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 24
|
-5.23 mmHg
Standard Deviation 10.793
|
-8.62 mmHg
Standard Deviation 10.066
|
-7.19 mmHg
Standard Deviation 10.504
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 1
|
-7.93 mmHg
Standard Deviation 10.377
|
-7.38 mmHg
Standard Deviation 8.786
|
-5.99 mmHg
Standard Deviation 11.811
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 2
|
-8.47 mmHg
Standard Deviation 12.343
|
-10.19 mmHg
Standard Deviation 10.836
|
-10.49 mmHg
Standard Deviation 12.803
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 3
|
-9.24 mmHg
Standard Deviation 13.445
|
-9.90 mmHg
Standard Deviation 11.353
|
-9.28 mmHg
Standard Deviation 11.828
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 4
|
-6.86 mmHg
Standard Deviation 13.397
|
-8.65 mmHg
Standard Deviation 11.740
|
-9.80 mmHg
Standard Deviation 12.802
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 5
|
-5.27 mmHg
Standard Deviation 14.782
|
-10.79 mmHg
Standard Deviation 12.123
|
-8.54 mmHg
Standard Deviation 15.816
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 6
|
-7.83 mmHg
Standard Deviation 12.628
|
-11.47 mmHg
Standard Deviation 13.154
|
-5.55 mmHg
Standard Deviation 14.870
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 7
|
-7.15 mmHg
Standard Deviation 13.876
|
-9.13 mmHg
Standard Deviation 12.990
|
-6.23 mmHg
Standard Deviation 14.911
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 8
|
-8.00 mmHg
Standard Deviation 11.858
|
-8.90 mmHg
Standard Deviation 11.220
|
-7.44 mmHg
Standard Deviation 13.863
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 9
|
-8.88 mmHg
Standard Deviation 8.732
|
-9.56 mmHg
Standard Deviation 12.309
|
-6.83 mmHg
Standard Deviation 13.290
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 10
|
-6.89 mmHg
Standard Deviation 10.063
|
-8.14 mmHg
Standard Deviation 11.244
|
-7.07 mmHg
Standard Deviation 13.808
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 11
|
-5.22 mmHg
Standard Deviation 12.401
|
-8.69 mmHg
Standard Deviation 12.989
|
-5.41 mmHg
Standard Deviation 12.983
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 12
|
-402 mmHg
Standard Deviation 13.637
|
-7.39 mmHg
Standard Deviation 13.722
|
-5.64 mmHg
Standard Deviation 12.158
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 14
|
-4.34 mmHg
Standard Deviation 12.057
|
-6.73 mmHg
Standard Deviation 11.751
|
-3.97 mmHg
Standard Deviation 14.844
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 15
|
-4.53 mmHg
Standard Deviation 13.244
|
-5.51 mmHg
Standard Deviation 10.473
|
-3.85 mmHg
Standard Deviation 11.421
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 16
|
-3.91 mmHg
Standard Deviation 11.469
|
-7.20 mmHg
Standard Deviation 10.179
|
-2.60 mmHg
Standard Deviation 11.997
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 17
|
-6.68 mmHg
Standard Deviation 11.774
|
-7.21 mmHg
Standard Deviation 10.460
|
-4.43 mmHg
Standard Deviation 11.789
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 18
|
-5.87 mmHg
Standard Deviation 12.152
|
-6.94 mmHg
Standard Deviation 10.904
|
-6.36 mmHg
Standard Deviation 11.225
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 19
|
-5.32 mmHg
Standard Deviation 9.200
|
-7.61 mmHg
Standard Deviation 11.841
|
-3.94 mmHg
Standard Deviation 11.700
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 20
|
-5.17 mmHg
Standard Deviation 16.028
|
-10.45 mmHg
Standard Deviation 10.969
|
-3.06 mmHg
Standard Deviation 10.965
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 21
|
-6.97 mmHg
Standard Deviation 12.581
|
-9.44 mmHg
Standard Deviation 9.303
|
-6.33 mmHg
Standard Deviation 12.257
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hour 22
|
-7.57 mmHg
Standard Deviation 11.891
|
-11.37 mmHg
Standard Deviation 10.507
|
-6.61 mmHg
Standard Deviation 12.324
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed
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
Outcome measures
| Measure |
LCZ696 200 mg
n=165 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=156 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=148 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 17
|
-14.00 mmHg
Standard Deviation 16.145
|
-14.71 mmHg
Standard Deviation 16.069
|
-11.71 mmHg
Standard Deviation 17.849
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 3
|
-10.03 mmHg
Standard Deviation 15.654
|
-9.82 mmHg
Standard Deviation 18.755
|
-9.10 mmHg
Standard Deviation 17.448
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 18
|
-15.93 mmHg
Standard Deviation 16.180
|
-15.37 mmHg
Standard Deviation 14.999
|
-9.97 mmHg
Standard Deviation 17.116
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 1
|
-11.29 mmHg
Standard Deviation 15.196
|
-10.38 mmHg
Standard Deviation 15.257
|
-9.37 mmHg
Standard Deviation 16.751
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 2
|
-10.51 mmHg
Standard Deviation 16.652
|
-11.07 mmHg
Standard Deviation 17.183
|
-10.26 mmHg
Standard Deviation 16.202
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 4
|
-8.79 mmHg
Standard Deviation 17.070
|
-5.77 mmHg
Standard Deviation 17.588
|
-7.55 mmHg
Standard Deviation 19.225
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 5
|
-7.84 mmHg
Standard Deviation 17.290
|
-8.15 mmHg
Standard Deviation 16.984
|
-6.40 mmHg
Standard Deviation 19.817
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 6
|
-8.71 mmHg
Standard Deviation 16.700
|
-7.77 mmHg
Standard Deviation 17.722
|
-6.51 mmHg
Standard Deviation 19.439
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 7
|
-9.07 mmHg
Standard Deviation 17.599
|
-8.27 mmHg
Standard Deviation 19.157
|
-6.93 mmHg
Standard Deviation 17.751
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 8
|
-11.07 mmHg
Standard Deviation 16.115
|
-8.30 mmHg
Standard Deviation 16.824
|
-6.36 mmHg
Standard Deviation 18.156
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 9
|
-10.31 mmHg
Standard Deviation 16.749
|
-10.65 mmHg
Standard Deviation 15.636
|
-8.70 mmHg
Standard Deviation 18.304
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 10
|
-11.48 mmHg
Standard Deviation 16.782
|
-10.68 mmHg
Standard Deviation 17.256
|
-7.55 mmHg
Standard Deviation 18.870
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 11
|
-10.01 mmHg
Standard Deviation 15.182
|
-8.96 mmHg
Standard Deviation 19.195
|
-9.49 mmHg
Standard Deviation 17.537
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 12
|
-12.37 mmHg
Standard Deviation 15.745
|
-11.55 mmHg
Standard Deviation 18.456
|
-8.25 mmHg
Standard Deviation 17.806
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 13
|
-13.49 mmHg
Standard Deviation 17.706
|
10.64 mmHg
Standard Deviation 19.736
|
-9.82 mmHg
Standard Deviation 18.908
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 14
|
-13.20 mmHg
Standard Deviation 16.747
|
-13.34 mmHg
Standard Deviation 18.467
|
-10.24 mmHg
Standard Deviation 17.972
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 15
|
-14.01 mmHg
Standard Deviation 17.729
|
-11.95 mmHg
Standard Deviation 16.789
|
-12.62 mmHg
Standard Deviation 16.855
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 16
|
-15.15 mmHg
Standard Deviation 15.683
|
-14.04 mmHg
Standard Deviation 15.090
|
-12.52 mmHg
Standard Deviation 15.137
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 19
|
-16.45 mmHg
Standard Deviation 16.800
|
-16.04 mmHg
Standard Deviation 15.968
|
-10.37 mmHg
Standard Deviation 15.684
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 20
|
-15.29 mmHg
Standard Deviation 16.220
|
-14.20 mmHg
Standard Deviation 16.727
|
-10.90 mmHg
Standard Deviation 15.129
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 21
|
-14.10 mmHg
Standard Deviation 15.413
|
-15.26 mmHg
Standard Deviation 17.307
|
-10.52 mmHg
Standard Deviation 16.818
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 22
|
-13.97 mmHg
Standard Deviation 15.504
|
-12.79 mmHg
Standard Deviation 14.252
|
-10.67 mmHg
Standard Deviation 17.877
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 23
|
-11.91 mmHg
Standard Deviation 15.622
|
-9.55 mmHg
Standard Deviation 17.616
|
-10.77 mmHg
Standard Deviation 15.363
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hour 24
|
-13.07 mmHg
Standard Deviation 15.572
|
-11.81 mmHg
Standard Deviation 16.006
|
-7.57 mmHg
Standard Deviation 15.992
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed
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
Outcome measures
| Measure |
LCZ696 200 mg
n=165 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=156 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=148 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 7
|
-4.85 mmHg
Standard Deviation 12.321
|
-3.31 mmHg
Standard Deviation 12.281
|
-2.71 mmHg
Standard Deviation 13.000
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 8
|
-6.07 mmHg
Standard Deviation 11.764
|
-2.22 mmHg
Standard Deviation 11.449
|
-3.44 mmHg
Standard Deviation 12.022
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 12
|
-5.43 mmHg
Standard Deviation 10.795
|
-4.42 mmHg
Standard Deviation 11.973
|
-4.50 mmHg
Standard Deviation 11.743
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 15
|
-7.29 mmHg
Standard Deviation 12.351
|
-5.95 mmHg
Standard Deviation 11.443
|
-7.52 mmHg
Standard Deviation 12.395
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 1
|
-5.93 mmHg
Standard Deviation 9.153
|
-6.57 mmHg
Standard Deviation 10.350
|
-4.57 mmHg
Standard Deviation 10.648
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 2
|
-5.41 mmHg
Standard Deviation 10.593
|
-551 mmHg
Standard Deviation 11.655
|
-5.49 mmHg
Standard Deviation 11.892
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 3
|
-3.95 mmHg
Standard Deviation 11.359
|
-4.20 mmHg
Standard Deviation 12.472
|
-4.44 mmHg
Standard Deviation 12.069
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 4
|
-3.68 mmHg
Standard Deviation 13.107
|
-3.53 mmHg
Standard Deviation 11.966
|
-4.70 mmHg
Standard Deviation 12.290
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 5
|
-3.53 mmHg
Standard Deviation 13.159
|
-3.14 mmHg
Standard Deviation 12.208
|
-3.81 mmHg
Standard Deviation 13.309
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 6
|
-4.10 mmHg
Standard Deviation 12.180
|
-3.55 mmHg
Standard Deviation 10.888
|
-2.94 mmHg
Standard Deviation 13.162
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 9
|
-4.34 mmHg
Standard Deviation 11.489
|
-4.78 mmHg
Standard Deviation 10.645
|
-4.54 mmHg
Standard Deviation 12.454
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 10
|
-5.53 mmHg
Standard Deviation 10.639
|
-4.48 mmHg
Standard Deviation 10.549
|
-3.57 mmHg
Standard Deviation 12.906
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 11
|
-4.53 mmHg
Standard Deviation 10.520
|
-4.10 mmHg
Standard Deviation 11.889
|
-5.51 mmHg
Standard Deviation 13.254
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 13
|
-5.57 mmHg
Standard Deviation 12.269
|
-5.01 mmHg
Standard Deviation 13.670
|
-6.04 mmHg
Standard Deviation 12.832
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 14
|
-6.18 mmHg
Standard Deviation 12.291
|
-5.91 mmHg
Standard Deviation 12.409
|
-5.26 mmHg
Standard Deviation 12.249
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 16
|
-7.68 mmHg
Standard Deviation 12.231
|
-7.26 mmHg
Standard Deviation 10.726
|
-6.96 mmHg
Standard Deviation 11.524
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 17
|
-7.28 mmHg
Standard Deviation 12.097
|
-7.84 mmHg
Standard Deviation 11.479
|
-6.14 mmHg
Standard Deviation 12.302
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 18
|
-8.38 mmHg
Standard Deviation 11.421
|
-8.81 mmHg
Standard Deviation 10.385
|
-5.28 mmHg
Standard Deviation 12.401
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 19
|
-9.02 mmHg
Standard Deviation 11.661
|
-8.77 mmHg
Standard Deviation 10.560
|
-5.20 mmHg
Standard Deviation 11.211
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 20
|
-8.92 mmHg
Standard Deviation 11.687
|
-7.12 mmHg
Standard Deviation 10.020
|
-5.80 mmHg
Standard Deviation 11.234
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 21
|
-8.05 mmHg
Standard Deviation 10.480
|
-7.24 mmHg
Standard Deviation 12.056
|
-6.49 mmHg
Standard Deviation 12.078
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 22
|
-7.16 mmHg
Standard Deviation 10.060
|
-6.55 mmHg
Standard Deviation 8.317
|
-5.65 mmHg
Standard Deviation 11.711
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 23
|
-6.34 mmHg
Standard Deviation 10.752
|
-5.19 mmHg
Standard Deviation 11.593
|
-6.26 mmHg
Standard Deviation 9.552
|
|
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hour 24
|
-5.86 mmHg
Standard Deviation 9.930
|
-6.05 mmHg
Standard Deviation 9.926
|
-4.96 mmHg
Standard Deviation 9.716
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
Successful blood pressure control is defined as msSBP \<140 mmHg and msDBP \<90 mmHg.
Outcome measures
| Measure |
LCZ696 200 mg
n=477 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=469 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=481 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Number of Patients Achieving Successful Blood Pressure Control
|
256 Number of participants
|
270 Number of participants
|
235 Number of participants
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.
Outcome measures
| Measure |
LCZ696 200 mg
n=188 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=184 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=182 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Change From Baseline in Ambulatory Pulse Pressure
|
-5.78 mmHg
Standard Error 0.23
|
-5.98 mmHg
Standard Error 0.23
|
-4.58 mmHg
Standard Error 0.23
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments
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)
Outcome measures
| Measure |
LCZ696 200 mg
n=477 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=469 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=481 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Number of Responders
|
312 Participants
|
314 Participants
|
290 Participants
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Safety Set (SAF): All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment they received.
Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Outcome measures
| Measure |
LCZ696 200 mg
n=478 Participants
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
|
Olmesartan 20 mg
n=472 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
Olmesartan 20 mg
n=484 Participants
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
|
|---|---|---|---|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
Adverse events (non-serious and serious
|
143 Participants
|
132 Participants
|
134 Participants
|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
Serious adverse events
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
LCZ696 200 mg
Serious events: 5 serious events
Other events: 66 other events
Deaths: 0 deaths
LCZ696 400 mg
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
Olmesartan 20 mg
Serious events: 6 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCZ696 200 mg
n=478 participants at risk
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily
|
LCZ696 400 mg
n=472 participants at risk
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
|
Olmesartan 20 mg
n=484 participants at risk
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
|
|---|---|---|---|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/478
|
0.00%
0/472
|
0.21%
1/484
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/478
|
0.00%
0/472
|
0.21%
1/484
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/478
|
0.00%
0/472
|
0.21%
1/484
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.21%
1/478
|
0.00%
0/472
|
0.00%
0/484
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.21%
1/478
|
0.00%
0/472
|
0.00%
0/484
|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/478
|
0.00%
0/472
|
0.21%
1/484
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/478
|
0.21%
1/472
|
0.00%
0/484
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.21%
1/478
|
0.00%
0/472
|
0.00%
0/484
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.21%
1/478
|
0.00%
0/472
|
0.00%
0/484
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/478
|
0.00%
0/472
|
0.21%
1/484
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/478
|
0.21%
1/472
|
0.00%
0/484
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.00%
0/478
|
0.21%
1/472
|
0.00%
0/484
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.21%
1/478
|
0.00%
0/472
|
0.00%
0/484
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.21%
1/478
|
0.00%
0/472
|
0.00%
0/484
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/478
|
0.00%
0/472
|
0.21%
1/484
|
Other adverse events
| Measure |
LCZ696 200 mg
n=478 participants at risk
Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily
|
LCZ696 400 mg
n=472 participants at risk
Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
|
Olmesartan 20 mg
n=484 participants at risk
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
|
|---|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.1%
15/478
|
1.1%
5/472
|
1.7%
8/484
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
1.0%
5/478
|
2.1%
10/472
|
2.7%
13/484
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
3.3%
16/478
|
4.7%
22/472
|
4.3%
21/484
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
2.9%
14/478
|
2.8%
13/472
|
3.3%
16/484
|
|
Nervous system disorders
DIZZINESS
|
1.7%
8/478
|
2.3%
11/472
|
0.62%
3/484
|
|
Nervous system disorders
HEADACHE
|
1.3%
6/478
|
0.85%
4/472
|
2.1%
10/484
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.3%
11/478
|
1.1%
5/472
|
0.62%
3/484
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER