Trial Outcomes & Findings for Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension (NCT NCT01615198)
NCT ID: NCT01615198
Last Updated: 2015-10-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
588 participants
Primary outcome timeframe
Baseline, 10 weeks
Results posted on
2015-10-23
Participant Flow
Participant milestones
| Measure |
LCZ696
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Overall Study
STARTED
|
296
|
292
|
|
Overall Study
Full Analysis Set
|
296
|
292
|
|
Overall Study
Ambulatory BP Monitoring (ABPM) Subset
|
154
|
157
|
|
Overall Study
Safety Set
|
296
|
292
|
|
Overall Study
ABPM Dipper Status Subset
|
82
|
84
|
|
Overall Study
COMPLETED
|
272
|
273
|
|
Overall Study
NOT COMPLETED
|
24
|
19
|
Reasons for withdrawal
| Measure |
LCZ696
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Protocol deviation
|
1
|
1
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
6
|
|
Overall Study
Adverse Event
|
11
|
5
|
Baseline Characteristics
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
Baseline characteristics by cohort
| Measure |
LCZ696
n=296 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=292 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
Total
n=588 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 Years
STANDARD_DEVIATION 4.67 • n=5 Participants
|
70.9 Years
STANDARD_DEVIATION 4.67 • n=7 Participants
|
70.7 Years
STANDARD_DEVIATION 4.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 10 weeksPopulation: Only participants, who had both baseline and week 10 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 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.
Outcome measures
| Measure |
LCZ696
n=295 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=291 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
|
-22.71 mmHg
Standard Error 0.91
|
-16.11 mmHg
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline, 10 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
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.
Outcome measures
| Measure |
LCZ696
n=154 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=157 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
|
-14.23 mmHg
Standard Error 0.56
|
-9.14 mmHg
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 14 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, 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 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.
Outcome measures
| Measure |
LCZ696
n=295 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=291 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
msSBP, week 4
|
-17.64 mmHg
Standard Error 0.83
|
-15.81 mmHg
Standard Error 0.84
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
msDBP, week 4
|
-6.08 mmHg
Standard Error 0.44
|
-5.58 mmHg
Standard Error 0.45
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
msSBP, week 14
|
-22.53 mmHg
Standard Error 0.92
|
-16.75 mmHg
Standard Error 0.94
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
msDBP, week 14
|
-7.92 mmHg
Standard Error 0.49
|
-5.97 mmHg
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline, 10 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
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.
Outcome measures
| Measure |
LCZ696
n=154 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=157 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
|
-6.95 mmHg
Standard Error 0.31
|
-4.47 mmHg
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline, 10 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and week 10 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
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.
Outcome measures
| Measure |
LCZ696
n=295 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=291 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
|
-8.58 mmHg
Standard Error 0.47
|
-6.49 mmHg
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 10 weeks, 14 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and post baseline values at the given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.
Outcome measures
| Measure |
LCZ696
n=295 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=291 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Pulse Pressure
week 4
|
-11.57 mmHg
Standard Error 0.60
|
-10.38 mmHg
Standard Error 0.61
|
|
Change From Baseline in Mean Sitting Pulse Pressure
week 10
|
-14.21 mmHg
Standard Error 0.63
|
-9.76 mmHg
Standard Error 0.64
|
|
Change From Baseline in Mean Sitting Pulse Pressure
week 14
|
-14.65 mmHg
Standard Error 0.64
|
-10.90 mmHg
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Baseline, 10 weeksPopulation: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
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.
Outcome measures
| Measure |
LCZ696
n=154 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=157 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in Daytime and Nighttime maSBP/maDBP
maSBP, daytime
|
-14.32 mmHg
Standard Error 0.96
|
-10.02 mmHg
Standard Error 0.96
|
|
Change From Baseline in Daytime and Nighttime maSBP/maDBP
maSBP, nighttime
|
-13.97 mmHg
Standard Error 0.96
|
-7.68 mmHg
Standard Error 0.96
|
|
Change From Baseline in Daytime and Nighttime maSBP/maDBP
maDBP, daytime
|
-7.04 mmHg
Standard Error 0.55
|
-4.88 mmHg
Standard Error 0.56
|
|
Change From Baseline in Daytime and Nighttime maSBP/maDBP
maDBP, nighttime
|
-6.70 mmHg
Standard Error 0.55
|
-3.61 mmHg
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline, 10 weeksPopulation: A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.
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.
Outcome measures
| Measure |
LCZ696
n=82 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=84 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 13 (n=-62,68)
|
-4.36 mmHg
Standard Deviation 11.325
|
-7.16 mmHg
Standard Deviation 12.916
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 14 (n=62,68)
|
-2.70 mmHg
Standard Deviation 13.661
|
-6.28 mmHg
Standard Deviation 10.794
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 15 (n=62,67)
|
-4.02 mmHg
Standard Deviation 12.943
|
-3.05 mmHg
Standard Deviation 11.417
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 16 (n=62,68)
|
-4.84 mmHg
Standard Deviation 13.097
|
-3.88 mmHg
Standard Deviation 10.015
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 17 (n=62,68)
|
-5.71 mmHg
Standard Deviation 12.089
|
-3.74 mmHg
Standard Deviation 11.261
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 18 (n=61,68)
|
-5.36 mmHg
Standard Deviation 11.213
|
-1.65 mmHg
Standard Deviation 8.939
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 19 (n=62,68)
|
-6.10 mmHg
Standard Deviation 11.197
|
-3.42 mmHg
Standard Deviation 9.726
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 20 (n=62,68)
|
-6.75 mmHg
Standard Deviation 10.878
|
-4.00 mmHg
Standard Deviation 12.452
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 21 (n=62,67)
|
-6.91 mmHg
Standard Deviation 12.251
|
-4.40 mmHg
Standard Deviation 9.746
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 22 (n=62,68)
|
-10.22 mmHg
Standard Deviation 11.394
|
-4.48 mmHg
Standard Deviation 11.019
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 23 (n=60,66)
|
-7.85 mmHg
Standard Deviation 9.030
|
-5.11 mmHg
Standard Deviation 9.826
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 24 (n=57,67)
|
-7.83 mmHg
Standard Deviation 10.057
|
-6.62 mmHg
Standard Deviation 10.418
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 1 (n=58,66)
|
-18.48 mmHg
Standard Deviation 14.550
|
-14.15 mmHg
Standard Deviation 15.677
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 2 (n=62,66)
|
-20.75 mmHg
Standard Deviation 15.713
|
-17.26 mmHg
Standard Deviation 16.843
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 3 (n=62,68)
|
-17.44 mmHg
Standard Deviation 18.884
|
-12.65 mmHg
Standard Deviation 18.923
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 4 (n=62,68)
|
-16.90 mmHg
Standard Deviation 16.539
|
-14.83 mmHg
Standard Deviation 17.823
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 5 (n=61,67)
|
-16.70 mmHg
Standard Deviation 17.689
|
-16.16 mmHg
Standard Deviation 19.460
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 6 (n=62,68)
|
-18.11 mmHg
Standard Deviation 17.856
|
-15.00 mmHg
Standard Deviation 19.025
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 7 (n=62,68)
|
-17.60 mmHg
Standard Deviation 18.330
|
-14.74 mmHg
Standard Deviation 20.142
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 8 (n=62,67)
|
-15.81 mmHg
Standard Deviation 15.872
|
-16.37 mmHg
Standard Deviation 17.552
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 9 (n=62,68)
|
-14.06 mmHg
Standard Deviation 12.877
|
-13.55 mmHg
Standard Deviation 19.456
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 10 (n=62,68)
|
-15.55 mmHg
Standard Deviation 15.232
|
-13.50 mmHg
Standard Deviation 17.522
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 11 (n=62,68)
|
-13.17 mmHg
Standard Deviation 17.903
|
-13.32 mmHg
Standard Deviation 18.198
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 12 (n=62,68)
|
-12.36 mmHg
Standard Deviation 17.222
|
-13.43 mmHg
Standard Deviation 20.898
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 13 (n=62,68)
|
-8.71 mmHg
Standard Deviation 19.359
|
-10.84 mmHg
Standard Deviation 19.697
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 14 (n=62,68)
|
-7.10 mmHg
Standard Deviation 20.651
|
-9.96 mmHg
Standard Deviation 19.663
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 15 (n=62,67)
|
-9.05 mmHg
Standard Deviation 18.528
|
-8.68 mmHg
Standard Deviation 17.094
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 16 (n=62,68)
|
-9.90 mmHg
Standard Deviation 17.994
|
-7.81 mmHg
Standard Deviation 16.344
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 17 (n=62,68)
|
-9.88 mmHg
Standard Deviation 16.098
|
-5.49 mmHg
Standard Deviation 15.031
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 18 (n=61,68)
|
-11.19 mmHg
Standard Deviation 16.482
|
-4.88 mmHg
Standard Deviation 13.065
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 19 (n=62,68)
|
-12.38 mmHg
Standard Deviation 15.010
|
-6.69 mmHg
Standard Deviation 15.146
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 20 (n=62,68)
|
-15.18 mmHg
Standard Deviation 16.683
|
-9.40 mmHg
Standard Deviation 18.217
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 21 (n=62,67)
|
-13.71 mmHg
Standard Deviation 19.977
|
-9.04 mmHg
Standard Deviation 15.748
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 22 (n=62,68)
|
-19.28 mmHg
Standard Deviation 19.387
|
-9.61 mmHg
Standard Deviation 18.940
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 23 (n=60,66)
|
-16.88 mmHg
Standard Deviation 15.442
|
-10.54 mmHg
Standard Deviation 19.470
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maSBP, hour 24 (n=57,67)
|
-17.28 mmHg
Standard Deviation 13.472
|
-16.03 mmHg
Standard Deviation 19.076
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 1 (n=58,66)
|
-8.34 mmHg
Standard Deviation 9.640
|
-7.30 mmHg
Standard Deviation 8.732
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 2 (n=62,66)
|
-9.13 mmHg
Standard Deviation 9.854
|
-7.80 mmHg
Standard Deviation 10.747
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 3 (n=62,68)
|
-8.41 mmHg
Standard Deviation 11.698
|
-8.21 mmHg
Standard Deviation 9.857
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 4 (n=62,68)
|
-7.35 mmHg
Standard Deviation 10.656
|
-8.98 mmHg
Standard Deviation 9.835
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 5 (n=61,67)
|
-8.17 mmHg
Standard Deviation 10.919
|
-8.35 mmHg
Standard Deviation 10.282
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 6 (n=62,68)
|
-8.39 mmHg
Standard Deviation 10.623
|
-8.09 mmHg
Standard Deviation 12.360
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 7 (n=62,68)
|
-9.14 mmHg
Standard Deviation 11.350
|
-7.35 mmHg
Standard Deviation 12.345
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 8 (n=62,67)
|
-7.50 mmHg
Standard Deviation 9.680
|
-8.50 mmHg
Standard Deviation 10.839
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 9 (n=62,68)
|
-7.01 mmHg
Standard Deviation 9.374
|
-6.65 mmHg
Standard Deviation 12.287
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 10 (n=62,68)
|
-7.83 mmHg
Standard Deviation 9.907
|
-6.70 mmHg
Standard Deviation 11.536
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 11 (n=62,68)
|
-8.08 mmHg
Standard Deviation 10.588
|
-6.65 mmHg
Standard Deviation 11.023
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
maDBP, hour 12 (n=62,68)
|
-7.38 mmHg
Standard Deviation 11.993
|
-7.64 mmHg
Standard Deviation 13.479
|
SECONDARY outcome
Timeframe: Baseline, 10 weeksPopulation: A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.
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.
Outcome measures
| Measure |
LCZ696
n=123 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=116 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 4 (n=91,88)
|
-13.93 mmHg
Standard Deviation 17.260
|
-4.98 mmHg
Standard Deviation 16.155
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 1 (n=84,84)
|
-13.42 mmHg
Standard Deviation 16.050
|
-9.53 mmHg
Standard Deviation 18.224
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 2 (n=89,85)
|
-15.60 mmHg
Standard Deviation 18.144
|
-8.57 mmHg
Standard Deviation 17.848
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 3 (n=90,88)
|
-13.17 mmHg
Standard Deviation 15.690
|
-6.33 mmHg
Standard Deviation 17.694
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 5 (n=90,88)
|
-12.90 mmHg
Standard Deviation 19.372
|
-4.68 mmHg
Standard Deviation 16.264
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 6 (n=90,89)
|
-12.96 mmHg
Standard Deviation 22.547
|
-5.49 mmHg
Standard Deviation 18.843
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 7 (n=91,89)
|
-12.68 mmHg
Standard Deviation 21.126
|
-6.64 mmHg
Standard Deviation 17.191
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 8 (n=91,88)
|
-12.65 mmHg
Standard Deviation 18.450
|
-7.45 mmHg
Standard Deviation 17.912
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 9 (n=91,89)
|
-13.51 mmHg
Standard Deviation 17.381
|
-7.81 mmHg
Standard Deviation 16.968
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 10 (n=92,89)
|
-12.96 mmHg
Standard Deviation 17.350
|
-7.63 mmHg
Standard Deviation 18.620
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 11 (n=92,89)
|
-12.69 mmHg
Standard Deviation 18.724
|
-6.89 mmHg
Standard Deviation 16.115
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 12 (n=92,88)
|
-13.82 mmHg
Standard Deviation 17.493
|
-3.92 mmHg
Standard Deviation 17.244
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 13 (n=92,89)
|
-16.51 mmHg
Standard Deviation 16.485
|
-5.49 mmHg
Standard Deviation 18.209
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 14 (n=92,88)
|
-19.39 mmHg
Standard Deviation 16.860
|
-5.16 mmHg
Standard Deviation 16.856
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 15 (n=92,89)
|
-19.33 mmHg
Standard Deviation 19.863
|
-5.92 mmHg
Standard Deviation 17.627
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 16 (n=92,89)
|
-17.95 mmHg
Standard Deviation 18.731
|
-6.57 mmHg
Standard Deviation 18.512
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 17 (n=92,89)
|
-17.34 mmHg
Standard Deviation 17.015
|
-12.03 mmHg
Standard Deviation 18.990
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 18 (n=92,88)
|
-16.45 mmHg
Standard Deviation 16.439
|
-8.54 mmHg
Standard Deviation 17.397
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 19 (n=91,89)
|
-15.81 mmHg
Standard Deviation 16.349
|
-9.33 mmHg
Standard Deviation 17.027
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 20 (n=92,89)
|
-15.33 mmHg
Standard Deviation 15.556
|
-6.77 mmHg
Standard Deviation 16.228
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 21 (n=91,89)
|
-14.78 mmHg
Standard Deviation 15.790
|
-7.10 mmHg
Standard Deviation 17.961
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 22 (n=91,89)
|
-13.99 mmHg
Standard Deviation 15.653
|
-6.05 mmHg
Standard Deviation 15.806
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 23 (n=92,85)
|
-10.93 mmHg
Standard Deviation 14.121
|
-8.48 mmHg
Standard Deviation 16.760
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
maSBP, hour 24 (n=86,85)
|
-14.19 mmHg
Standard Deviation 15.072
|
-7.98 mmHg
Standard Deviation 16.160
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 1 (n=84,84)
|
-7.01 mmHg
Standard Deviation 9.033
|
-4.59 mmHg
Standard Deviation 10.061
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 2 (n=89,85)
|
-7.39 mmHg
Standard Deviation 10.516
|
-3.32 mmHg
Standard Deviation 11.104
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 3 (n=90,88)
|
-6.61 mmHg
Standard Deviation 10.473
|
-3.77 mmHg
Standard Deviation 12.284
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 4 (n=91,88)
|
-7.08 mmHg
Standard Deviation 9.826
|
-2.24 mmHg
Standard Deviation 11.169
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 5 (n=90,88)
|
-5.75 mmHg
Standard Deviation 13.156
|
-1.53 mmHg
Standard Deviation 12.069
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 6 (n=90,89)
|
-7.06 mmHg
Standard Deviation 13.704
|
-2.00 mmHg
Standard Deviation 11.418
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 7 (n=91,89)
|
-5.69 mmHg
Standard Deviation 12.453
|
-1.70 mmHg
Standard Deviation 11.797
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 8 (n=91,88)
|
-6.13 mmHg
Standard Deviation 10.420
|
-3.04 mmHg
Standard Deviation 11.240
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 9 (n=91,89)
|
-7.05 mmHg
Standard Deviation 10.348
|
-3.62 mmHg
Standard Deviation 10.743
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 10 (n=92,89)
|
-5.28 mmHg
Standard Deviation 10.221
|
-3.14 mmHg
Standard Deviation 10.849
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 11 (n=92,89)
|
-6.18 mmHg
Standard Deviation 11.825
|
-3.18 mmHg
Standard Deviation 10.216
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 12 (n=92,88)
|
-6.36 mmHg
Standard Deviation 11.313
|
-1.61 mmHg
Standard Deviation 10.970
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 13 (n=92,89)
|
-8.63 mmHg
Standard Deviation 11.364
|
-2.41 mmHg
Standard Deviation 10.750
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 14 (n=92,88)
|
-9.68 mmHg
Standard Deviation 11.518
|
-1.69 mmHg
Standard Deviation 11.103
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 15 (n=92,89)
|
-9.60 mmHg
Standard Deviation 13.266
|
-2.85 mmHg
Standard Deviation 11.012
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 16 (n=92,89)
|
-8.48 mmHg
Standard Deviation 11.992
|
-2.54 mmHg
Standard Deviation 11.523
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 17 (n=92,89)
|
-7.60 mmHg
Standard Deviation 9.661
|
-5.44 mmHg
Standard Deviation 11.105
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 18 (n=92,88)
|
-8.60 mmHg
Standard Deviation 11.526
|
-4.25 mmHg
Standard Deviation 11.062
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 19 (n=91,89)
|
-7.46 mmHg
Standard Deviation 10.284
|
-3.93 mmHg
Standard Deviation 11.088
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 20 (n=92,89)
|
-6.21 mmHg
Standard Deviation 10.295
|
-3.10 mmHg
Standard Deviation 9.792
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 21 (n=91,89)
|
-7.63 mmHg
Standard Deviation 10.871
|
-2.81 mmHg
Standard Deviation 11.002
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 22 (n=91,89)
|
-6.97 mmHg
Standard Deviation 10.589
|
-2.60 mmHg
Standard Deviation 10.568
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 23 (n=92,85)
|
-5.72 mmHg
Standard Deviation 9.410
|
-2.12 mmHg
Standard Deviation 11.612
|
|
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
msDBP, hour 24 (n=86,85)
|
-6.57 mmHg
Standard Deviation 9.916
|
-3.91 mmHg
Standard Deviation 9.240
|
SECONDARY outcome
Timeframe: 4 weeks, 10 weeks, 14 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg.
Outcome measures
| Measure |
LCZ696
n=295 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=291 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
4 weeks
|
140 Participants
|
120 Participants
|
|
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
10 weeks
|
175 Participants
|
130 Participants
|
|
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
14 weeks
|
173 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 4 weeks,10 weeks, 14 weeksPopulation: Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
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.
Outcome measures
| Measure |
LCZ696
n=295 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=291 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Number of Participants Achieving Successful Response in msSBP and msDBP
msSBP, week 4
|
162 Participants
|
146 Participants
|
|
Number of Participants Achieving Successful Response in msSBP and msDBP
msSBP, week 10
|
208 Participants
|
142 Participants
|
|
Number of Participants Achieving Successful Response in msSBP and msDBP
msSBP, week 14
|
205 Participants
|
144 Participants
|
|
Number of Participants Achieving Successful Response in msSBP and msDBP
msDBP, week 4
|
264 Participants
|
245 Participants
|
|
Number of Participants Achieving Successful Response in msSBP and msDBP
msDBP, week 10
|
275 Participants
|
254 Participants
|
|
Number of Participants Achieving Successful Response in msSBP and msDBP
msDBP, week 14
|
268 Participants
|
246 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Participants from the safety analysis set were analyzed. The safety analysis set included all randomized participants who received study medication and had post baseline assessments.
Adverse event monitoring was conducted throughout the study.
Outcome measures
| Measure |
LCZ696
n=296 Participants
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=292 Participants
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Adverse events (non-serious and serious)
|
141 Participants
|
113 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Deaths
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Serious adverse events
|
7 Participants
|
2 Participants
|
Adverse Events
LCZ696
Serious events: 7 serious events
Other events: 49 other events
Deaths: 0 deaths
Olmesartan
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCZ696
n=296 participants at risk
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=292 participants at risk
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Cardiac disorders
ARRHYTHMIA
|
0.34%
1/296
|
0.00%
0/292
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.34%
1/296
|
0.00%
0/292
|
|
Ear and labyrinth disorders
VERTIGO
|
0.34%
1/296
|
0.00%
0/292
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.34%
1/296
|
0.00%
0/292
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.34%
1/296
|
0.00%
0/292
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/296
|
0.34%
1/292
|
|
Musculoskeletal and connective tissue disorders
MUSCLE ATROPHY
|
0.34%
1/296
|
0.00%
0/292
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.34%
1/296
|
0.00%
0/292
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.34%
1/296
|
0.00%
0/292
|
|
Renal and urinary disorders
HENOCH-SCHONLEIN PURPURA NEPHRITIS
|
0.00%
0/296
|
0.34%
1/292
|
Other adverse events
| Measure |
LCZ696
n=296 participants at risk
Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
|
Olmesartan
n=292 participants at risk
Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
|
|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
8.1%
24/296
|
6.2%
18/292
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.4%
10/296
|
2.1%
6/292
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
3.7%
11/296
|
6.5%
19/292
|
|
Nervous system disorders
DIZZINESS
|
2.0%
6/296
|
0.68%
2/292
|
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