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Trial record 19 of 134 for:    OLMESARTAN

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT01615198
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : August 18, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: Olmesartan
Drug: Placebo
Drug: LCZ696
Enrollment 588
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 296 292
Full Analysis Set 296 292
Ambulatory BP Monitoring (ABPM) Subset 154 157
Safety Set 296 292
ABPM Dipper Status Subset 82 84
Completed 272 273
Not Completed 24 19
Reason Not Completed
Withdrawal by Subject             5             5
Protocol deviation             1             1
Physician Decision             5             1
Lost to Follow-up             1             1
Lack of Efficacy             1             6
Adverse Event             11             5
Arm/Group Title LCZ696 Olmesartan Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 296 292 588
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants 292 participants 588 participants
70.5  (4.67) 70.9  (4.67) 70.7  (4.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 292 participants 588 participants
Female
154
  52.0%
140
  47.9%
294
  50.0%
Male
142
  48.0%
152
  52.1%
294
  50.0%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description 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.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 295 291
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-22.71  (0.91) -16.11  (0.92)
2.Secondary Outcome
Title Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Hide Description 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.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 157
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-14.23  (0.56) -9.14  (0.56)
3.Secondary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description 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.
Time Frame Baseline, 4 weeks, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 295 291
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
msSBP, week 4 -17.64  (0.83) -15.81  (0.84)
msDBP, week 4 -6.08  (0.44) -5.58  (0.45)
msSBP, week 14 -22.53  (0.92) -16.75  (0.94)
msDBP, week 14 -7.92  (0.49) -5.97  (0.49)
4.Secondary Outcome
Title Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Hide Description 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.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 157
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-6.95  (0.31) -4.47  (0.31)
5.Secondary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description 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.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 295 291
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-8.58  (0.47) -6.49  (0.48)
6.Secondary Outcome
Title Change From Baseline in Mean Sitting Pulse Pressure
Hide Description Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.
Time Frame Baseline, 4 weeks, 10 weeks, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 295 291
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
week 4 -11.57  (0.60) -10.38  (0.61)
week 10 -14.21  (0.63) -9.76  (0.64)
week 14 -14.65  (0.64) -10.90  (0.65)
7.Secondary Outcome
Title Change From Baseline in Daytime and Nighttime maSBP/maDBP
Hide Description 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.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 157
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
maSBP, daytime -14.32  (0.96) -10.02  (0.96)
maSBP, nighttime -13.97  (0.96) -7.68  (0.96)
maDBP, daytime -7.04  (0.55) -4.88  (0.56)
maDBP, nighttime -6.70  (0.55) -3.61  (0.56)
8.Secondary Outcome
Title Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
Hide Description 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.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 82 84
Mean (Standard Deviation)
Unit of Measure: mmHg
maSBP, hour 1 (n=58,66) -18.48  (14.550) -14.15  (15.677)
maSBP, hour 2 (n=62,66) -20.75  (15.713) -17.26  (16.843)
maSBP, hour 3 (n=62,68) -17.44  (18.884) -12.65  (18.923)
maSBP, hour 4 (n=62,68) -16.90  (16.539) -14.83  (17.823)
maSBP, hour 5 (n=61,67) -16.70  (17.689) -16.16  (19.460)
maSBP, hour 6 (n=62,68) -18.11  (17.856) -15.00  (19.025)
maSBP, hour 7 (n=62,68) -17.60  (18.330) -14.74  (20.142)
maSBP, hour 8 (n=62,67) -15.81  (15.872) -16.37  (17.552)
maSBP, hour 9 (n=62,68) -14.06  (12.877) -13.55  (19.456)
maSBP, hour 10 (n=62,68) -15.55  (15.232) -13.50  (17.522)
maSBP, hour 11 (n=62,68) -13.17  (17.903) -13.32  (18.198)
maSBP, hour 12 (n=62,68) -12.36  (17.222) -13.43  (20.898)
maSBP, hour 13 (n=62,68) -8.71  (19.359) -10.84  (19.697)
maSBP, hour 14 (n=62,68) -7.10  (20.651) -9.96  (19.663)
maSBP, hour 15 (n=62,67) -9.05  (18.528) -8.68  (17.094)
maSBP, hour 16 (n=62,68) -9.90  (17.994) -7.81  (16.344)
maSBP, hour 17 (n=62,68) -9.88  (16.098) -5.49  (15.031)
maSBP, hour 18 (n=61,68) -11.19  (16.482) -4.88  (13.065)
maSBP, hour 19 (n=62,68) -12.38  (15.010) -6.69  (15.146)
maSBP, hour 20 (n=62,68) -15.18  (16.683) -9.40  (18.217)
maSBP, hour 21 (n=62,67) -13.71  (19.977) -9.04  (15.748)
maSBP, hour 22 (n=62,68) -19.28  (19.387) -9.61  (18.940)
maSBP, hour 23 (n=60,66) -16.88  (15.442) -10.54  (19.470)
maSBP, hour 24 (n=57,67) -17.28  (13.472) -16.03  (19.076)
maDBP, hour 1 (n=58,66) -8.34  (9.640) -7.30  (8.732)
maDBP, hour 2 (n=62,66) -9.13  (9.854) -7.80  (10.747)
maDBP, hour 3 (n=62,68) -8.41  (11.698) -8.21  (9.857)
maDBP, hour 4 (n=62,68) -7.35  (10.656) -8.98  (9.835)
maDBP, hour 5 (n=61,67) -8.17  (10.919) -8.35  (10.282)
maDBP, hour 6 (n=62,68) -8.39  (10.623) -8.09  (12.360)
maDBP, hour 7 (n=62,68) -9.14  (11.350) -7.35  (12.345)
maDBP, hour 8 (n=62,67) -7.50  (9.680) -8.50  (10.839)
maDBP, hour 9 (n=62,68) -7.01  (9.374) -6.65  (12.287)
maDBP, hour 10 (n=62,68) -7.83  (9.907) -6.70  (11.536)
maDBP, hour 11 (n=62,68) -8.08  (10.588) -6.65  (11.023)
maDBP, hour 12 (n=62,68) -7.38  (11.993) -7.64  (13.479)
maDBP, hour 13 (n=-62,68) -4.36  (11.325) -7.16  (12.916)
maDBP, hour 14 (n=62,68) -2.70  (13.661) -6.28  (10.794)
maDBP, hour 15 (n=62,67) -4.02  (12.943) -3.05  (11.417)
maDBP, hour 16 (n=62,68) -4.84  (13.097) -3.88  (10.015)
maDBP, hour 17 (n=62,68) -5.71  (12.089) -3.74  (11.261)
maDBP, hour 18 (n=61,68) -5.36  (11.213) -1.65  (8.939)
maDBP, hour 19 (n=62,68) -6.10  (11.197) -3.42  (9.726)
maDBP, hour 20 (n=62,68) -6.75  (10.878) -4.00  (12.452)
maDBP, hour 21 (n=62,67) -6.91  (12.251) -4.40  (9.746)
maDBP, hour 22 (n=62,68) -10.22  (11.394) -4.48  (11.019)
maDBP, hour 23 (n=60,66) -7.85  (9.030) -5.11  (9.826)
maDBP, hour 24 (n=57,67) -7.83  (10.057) -6.62  (10.418)
9.Secondary Outcome
Title Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
Hide Description 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.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 123 116
Mean (Standard Deviation)
Unit of Measure: mmHg
maSBP, hour 1 (n=84,84) -13.42  (16.050) -9.53  (18.224)
maSBP, hour 2 (n=89,85) -15.60  (18.144) -8.57  (17.848)
maSBP, hour 3 (n=90,88) -13.17  (15.690) -6.33  (17.694)
maSBP, hour 4 (n=91,88) -13.93  (17.260) -4.98  (16.155)
maSBP, hour 5 (n=90,88) -12.90  (19.372) -4.68  (16.264)
maSBP, hour 6 (n=90,89) -12.96  (22.547) -5.49  (18.843)
maSBP, hour 7 (n=91,89) -12.68  (21.126) -6.64  (17.191)
maSBP, hour 8 (n=91,88) -12.65  (18.450) -7.45  (17.912)
maSBP, hour 9 (n=91,89) -13.51  (17.381) -7.81  (16.968)
maSBP, hour 10 (n=92,89) -12.96  (17.350) -7.63  (18.620)
maSBP, hour 11 (n=92,89) -12.69  (18.724) -6.89  (16.115)
maSBP, hour 12 (n=92,88) -13.82  (17.493) -3.92  (17.244)
maSBP, hour 13 (n=92,89) -16.51  (16.485) -5.49  (18.209)
maSBP, hour 14 (n=92,88) -19.39  (16.860) -5.16  (16.856)
maSBP, hour 15 (n=92,89) -19.33  (19.863) -5.92  (17.627)
maSBP, hour 16 (n=92,89) -17.95  (18.731) -6.57  (18.512)
maSBP, hour 17 (n=92,89) -17.34  (17.015) -12.03  (18.990)
maSBP, hour 18 (n=92,88) -16.45  (16.439) -8.54  (17.397)
maSBP, hour 19 (n=91,89) -15.81  (16.349) -9.33  (17.027)
maSBP, hour 20 (n=92,89) -15.33  (15.556) -6.77  (16.228)
maSBP, hour 21 (n=91,89) -14.78  (15.790) -7.10  (17.961)
maSBP, hour 22 (n=91,89) -13.99  (15.653) -6.05  (15.806)
maSBP, hour 23 (n=92,85) -10.93  (14.121) -8.48  (16.760)
maSBP, hour 24 (n=86,85) -14.19  (15.072) -7.98  (16.160)
msDBP, hour 1 (n=84,84) -7.01  (9.033) -4.59  (10.061)
msDBP, hour 2 (n=89,85) -7.39  (10.516) -3.32  (11.104)
msDBP, hour 3 (n=90,88) -6.61  (10.473) -3.77  (12.284)
msDBP, hour 4 (n=91,88) -7.08  (9.826) -2.24  (11.169)
msDBP, hour 5 (n=90,88) -5.75  (13.156) -1.53  (12.069)
msDBP, hour 6 (n=90,89) -7.06  (13.704) -2.00  (11.418)
msDBP, hour 7 (n=91,89) -5.69  (12.453) -1.70  (11.797)
msDBP, hour 8 (n=91,88) -6.13  (10.420) -3.04  (11.240)
msDBP, hour 9 (n=91,89) -7.05  (10.348) -3.62  (10.743)
msDBP, hour 10 (n=92,89) -5.28  (10.221) -3.14  (10.849)
msDBP, hour 11 (n=92,89) -6.18  (11.825) -3.18  (10.216)
msDBP, hour 12 (n=92,88) -6.36  (11.313) -1.61  (10.970)
msDBP, hour 13 (n=92,89) -8.63  (11.364) -2.41  (10.750)
msDBP, hour 14 (n=92,88) -9.68  (11.518) -1.69  (11.103)
msDBP, hour 15 (n=92,89) -9.60  (13.266) -2.85  (11.012)
msDBP, hour 16 (n=92,89) -8.48  (11.992) -2.54  (11.523)
msDBP, hour 17 (n=92,89) -7.60  (9.661) -5.44  (11.105)
msDBP, hour 18 (n=92,88) -8.60  (11.526) -4.25  (11.062)
msDBP, hour 19 (n=91,89) -7.46  (10.284) -3.93  (11.088)
msDBP, hour 20 (n=92,89) -6.21  (10.295) -3.10  (9.792)
msDBP, hour 21 (n=91,89) -7.63  (10.871) -2.81  (11.002)
msDBP, hour 22 (n=91,89) -6.97  (10.589) -2.60  (10.568)
msDBP, hour 23 (n=92,85) -5.72  (9.410) -2.12  (11.612)
msDBP, hour 24 (n=86,85) -6.57  (9.916) -3.91  (9.240)
10.Secondary Outcome
Title Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.
Time Frame 4 weeks, 10 weeks, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 295 291
Measure Type: Number
Unit of Measure: Participants
4 weeks 140 120
10 weeks 175 130
14 weeks 173 126
11.Secondary Outcome
Title Number of Participants Achieving Successful Response in msSBP and msDBP
Hide Description 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.
Time Frame 4 weeks,10 weeks, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 295 291
Measure Type: Number
Unit of Measure: Participants
msSBP, week 4 162 146
msSBP, week 10 208 142
msSBP, week 14 205 144
msDBP, week 4 264 245
msDBP, week 10 275 254
msDBP, week 14 268 246
12.Secondary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Death
Hide Description Adverse event monitoring was conducted throughout the study.
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 296 292
Measure Type: Number
Unit of Measure: Participants
Adverse events (non-serious and serious) 141 113
Serious adverse events 7 2
Deaths 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCZ696 Olmesartan
Hide Arm/Group Description 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. 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.
All-Cause Mortality
LCZ696 Olmesartan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCZ696 Olmesartan
Affected / at Risk (%) Affected / at Risk (%)
Total   7/296 (2.36%)   2/292 (0.68%) 
Cardiac disorders     
ARRHYTHMIA  1  1/296 (0.34%)  0/292 (0.00%) 
ATRIAL FIBRILLATION  1  1/296 (0.34%)  0/292 (0.00%) 
Ear and labyrinth disorders     
VERTIGO  1  1/296 (0.34%)  0/292 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/296 (0.34%)  0/292 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/296 (0.34%)  0/292 (0.00%) 
LIVER FUNCTION TEST ABNORMAL  1  0/296 (0.00%)  1/292 (0.34%) 
Musculoskeletal and connective tissue disorders     
MUSCLE ATROPHY  1  1/296 (0.34%)  0/292 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
CERVIX CARCINOMA  1  1/296 (0.34%)  0/292 (0.00%) 
Nervous system disorders     
CEREBRAL INFARCTION  1  1/296 (0.34%)  0/292 (0.00%) 
Renal and urinary disorders     
HENOCH-SCHONLEIN PURPURA NEPHRITIS  1  0/296 (0.00%)  1/292 (0.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
LCZ696 Olmesartan
Affected / at Risk (%) Affected / at Risk (%)
Total   49/296 (16.55%)   44/292 (15.07%) 
Infections and infestations     
NASOPHARYNGITIS  1  24/296 (8.11%)  18/292 (6.16%) 
UPPER RESPIRATORY TRACT INFECTION  1  10/296 (3.38%)  6/292 (2.05%) 
Metabolism and nutrition disorders     
HYPERURICAEMIA  1  11/296 (3.72%)  19/292 (6.51%) 
Nervous system disorders     
DIZZINESS  1  6/296 (2.03%)  2/292 (0.68%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01615198     History of Changes
Other Study ID Numbers: CLCZ696A2316
First Submitted: June 6, 2012
First Posted: June 8, 2012
Results First Submitted: July 20, 2015
Results First Posted: August 18, 2015
Last Update Posted: October 23, 2015