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Trial record 7 of 134 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT01785472
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : September 4, 2015
Last Update Posted : December 29, 2016
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: LCZ696
Drug: Olmesartan
Drug: Placebo of LCZ696
Drug: Placebo of Olmesartan
Enrollment 1438
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description 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. 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. Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Period Title: Overall Study
Started 479 473 486
Full Analysis Set (FAS) 479 472 484
Safety Set (SAF) 478 472 484
Completed 455 454 464
Not Completed 24 19 22
Reason Not Completed
Adverse Event             5             4             6
Lack of Efficacy             2             0             1
Lost to Follow-up             1             2             0
Physician Decision             1             1             1
Protocol deviation             0             2             2
Subject/guardian decision             15             10             11
Technical problems             0             0             1
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg Total
Hide Arm/Group Description 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. 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. Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. Total of all reporting groups
Overall Number of Baseline Participants 479 472 484 1435
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All patients who were randomized. Patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS, provided these patients did not receive study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 479 participants 472 participants 484 participants 1435 participants
57.5  (10.17) 58.1  (9.71) 57.4  (10.14) 57.7  (10.01)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 479 participants 472 participants 484 participants 1435 participants
Female
227
  47.4%
229
  48.5%
223
  46.1%
679
  47.3%
Male
252
  52.6%
243
  51.5%
261
  53.9%
756
  52.7%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
Hide Description 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.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 477 479
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-20.48  (0.61) -18.15  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCZ696 200 mg, Olmesartan 20 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The statistical test was made at a one-sided significance level of 0.025.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter least Square Means net difference
Estimated Value -2.33
Confidence Interval 95%
-4.00 to -0.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.85
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg
Hide Description 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
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 469 479
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-21.67  (0.62) -18.15  (0.61)
3.Secondary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg
Hide Description Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 477 469 479
Mean (Standard Error)
Unit of Measure: mmHg
-8.10  (0.37) -8.80  (0.38) -6.86  (0.37)
4.Secondary Outcome
Title Change From Baseline in Office Pulse Pressure (msPP)
Hide Description Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 477 469 479
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.35  (0.42) -12.93  (0.43) -11.25  (0.42)
5.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Blood Pressure
Hide Description 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.
Time Frame baseline, 8 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 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 188 184 182
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
maSBP -12.07  (0.49) -12.76  (0.49) -10.26  (0.49)
maDBP -6.36  (0.31) -6.82  (0.31) -5.61  (0.31)
6.Secondary Outcome
Title Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Hide Description 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
Time Frame baseline, 8 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 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 55 79 74
Mean (Standard Deviation)
Unit of Measure: mmHg
Hour 1 -13.22  (16.506) -15.02  (14.578) -9.07  (17.597)
Hour 2 -17.24  (20.423) -18.11  (15.343) -13.95  (19.247)
Hour 3 -14.99  (19.378) -16.83  (16.312) -14.51  (18.436)
Hour 4 -13.09  (19.460) -16.37  (18.710) -14.63  (18.824)
Hour 5 -11.19  (19.376) -18.88  (16.636) -14.64  (21.177)
Hour 6 -13.66  (16.785) -19.19  (17.771) -11.54  (21.885)
Hour 7 -11.74  (21.552) -18.07  (19.748) -11.74  (24.674)
Hour 8 -13.84  (17.365) -16.12  (16.696) -12.99  (20.555)
Hour 9 -16.33  (16.437) -15.64  (18.915) -13.33  (18.360)
Hour 10 -13.81  (17.670) 15.13  (18.014) -10.89  (19.814)
Hour 11 -12.98  (16.856) -15.93  (19.022) -7.66  (18.816)
Hour 12 -8.99  (17.913) -15.54  (20.397) -10.51  (19.516)
Hour 13 -12.46  (18.694) -13.28  (17.014) -11.49  (18.587)
Hour 14 -9.64  (17.001) -12.33  (16.449) -6.66  (17.906)
Hour 15 -7.73  (17.362) -10.12  (14.433) -7.81  (15.383)
Hour 16 -4.92  (14.788) -12.82  (13.386) -4.40  (15.974)
Hour 17 -10.20  (15.780) -12.43  (14.397) -7.19  (14.937)
Hour 18 -9.84  (15.789) -11.70  (13.799) -8.90  (14.907)
Hour 19 -8.94  (12.283) -12.20  (15.012) -5.76  (16.029)
Hour 20 -8.03  (19.411) -15.04  (14.647) -4.83  (15.953)
Hour 21 -9.47  (16.984) -14.33  (13.585) -9.97  (16.552)
Hour 22 -12.62  (17.527) -17.20  (14.304) -9.95  (18.490)
Hour 23 -9.23  (20.068) -16.63  (15.752) -14.09  (25.454)
Hour 24 -8.43  (15.330) -15.76  (17.392) -12.71  (15.199)
7.Secondary Outcome
Title Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Hide Description 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
Time Frame baseline, 8 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 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 55 79 74
Mean (Standard Deviation)
Unit of Measure: mmHg
Hour 1 -7.93  (10.377) -7.38  (8.786) -5.99  (11.811)
Hour 2 -8.47  (12.343) -10.19  (10.836) -10.49  (12.803)
Hour 3 -9.24  (13.445) -9.90  (11.353) -9.28  (11.828)
Hour 4 -6.86  (13.397) -8.65  (11.740) -9.80  (12.802)
Hour 5 -5.27  (14.782) -10.79  (12.123) -8.54  (15.816)
Hour 6 -7.83  (12.628) -11.47  (13.154) -5.55  (14.870)
Hour 7 -7.15  (13.876) -9.13  (12.990) -6.23  (14.911)
Hour 8 -8.00  (11.858) -8.90  (11.220) -7.44  (13.863)
Hour 9 -8.88  (8.732) -9.56  (12.309) -6.83  (13.290)
Hour 10 -6.89  (10.063) -8.14  (11.244) -7.07  (13.808)
Hour 11 -5.22  (12.401) -8.69  (12.989) -5.41  (12.983)
Hour 12 -402  (13.637) -7.39  (13.722) -5.64  (12.158)
Hour 13 -6.84  (12.616) -6.33  (10.802) -6.69  (14.822)
Hour 14 -4.34  (12.057) -6.73  (11.751) -3.97  (14.844)
Hour 15 -4.53  (13.244) -5.51  (10.473) -3.85  (11.421)
Hour 16 -3.91  (11.469) -7.20  (10.179) -2.60  (11.997)
Hour 17 -6.68  (11.774) -7.21  (10.460) -4.43  (11.789)
Hour 18 -5.87  (12.152) -6.94  (10.904) -6.36  (11.225)
Hour 19 -5.32  (9.200) -7.61  (11.841) -3.94  (11.700)
Hour 20 -5.17  (16.028) -10.45  (10.969) -3.06  (10.965)
Hour 21 -6.97  (12.581) -9.44  (9.303) -6.33  (12.257)
Hour 22 -7.57  (11.891) -11.37  (10.507) -6.61  (12.324)
Hour 23 -6.12  (13.266) -9.95  (10.374) -9.89  (15.553)
Hour 24 -5.23  (10.793) -8.62  (10.066) -7.19  (10.504)
8.Secondary Outcome
Title Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Hide Description 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
Time Frame baseline, 8 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 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 165 156 148
Mean (Standard Deviation)
Unit of Measure: mmHg
Hour 1 -11.29  (15.196) -10.38  (15.257) -9.37  (16.751)
Hour 2 -10.51  (16.652) -11.07  (17.183) -10.26  (16.202)
Hour 3 -10.03  (15.654) -9.82  (18.755) -9.10  (17.448)
Hour 4 -8.79  (17.070) -5.77  (17.588) -7.55  (19.225)
Hour 5 -7.84  (17.290) -8.15  (16.984) -6.40  (19.817)
Hour 6 -8.71  (16.700) -7.77  (17.722) -6.51  (19.439)
Hour 7 -9.07  (17.599) -8.27  (19.157) -6.93  (17.751)
Hour 8 -11.07  (16.115) -8.30  (16.824) -6.36  (18.156)
Hour 9 -10.31  (16.749) -10.65  (15.636) -8.70  (18.304)
Hour 10 -11.48  (16.782) -10.68  (17.256) -7.55  (18.870)
Hour 11 -10.01  (15.182) -8.96  (19.195) -9.49  (17.537)
Hour 12 -12.37  (15.745) -11.55  (18.456) -8.25  (17.806)
Hour 13 -13.49  (17.706) 10.64  (19.736) -9.82  (18.908)
Hour 14 -13.20  (16.747) -13.34  (18.467) -10.24  (17.972)
Hour 15 -14.01  (17.729) -11.95  (16.789) -12.62  (16.855)
Hour 16 -15.15  (15.683) -14.04  (15.090) -12.52  (15.137)
Hour 17 -14.00  (16.145) -14.71  (16.069) -11.71  (17.849)
Hour 18 -15.93  (16.180) -15.37  (14.999) -9.97  (17.116)
Hour 19 -16.45  (16.800) -16.04  (15.968) -10.37  (15.684)
Hour 20 -15.29  (16.220) -14.20  (16.727) -10.90  (15.129)
Hour 21 -14.10  (15.413) -15.26  (17.307) -10.52  (16.818)
Hour 22 -13.97  (15.504) -12.79  (14.252) -10.67  (17.877)
Hour 23 -11.91  (15.622) -9.55  (17.616) -10.77  (15.363)
Hour 24 -13.07  (15.572) -11.81  (16.006) -7.57  (15.992)
9.Secondary Outcome
Title Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Hide Description 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
Time Frame baseline, 8 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 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 165 156 148
Mean (Standard Deviation)
Unit of Measure: mmHg
Hour 1 -5.93  (9.153) -6.57  (10.350) -4.57  (10.648)
Hour 2 -5.41  (10.593) -551  (11.655) -5.49  (11.892)
Hour 3 -3.95  (11.359) -4.20  (12.472) -4.44  (12.069)
Hour 4 -3.68  (13.107) -3.53  (11.966) -4.70  (12.290)
Hour 5 -3.53  (13.159) -3.14  (12.208) -3.81  (13.309)
Hour 6 -4.10  (12.180) -3.55  (10.888) -2.94  (13.162)
Hour 7 -4.85  (12.321) -3.31  (12.281) -2.71  (13.000)
Hour 8 -6.07  (11.764) -2.22  (11.449) -3.44  (12.022)
Hour 9 -4.34  (11.489) -4.78  (10.645) -4.54  (12.454)
Hour 10 -5.53  (10.639) -4.48  (10.549) -3.57  (12.906)
Hour 11 -4.53  (10.520) -4.10  (11.889) -5.51  (13.254)
Hour 12 -5.43  (10.795) -4.42  (11.973) -4.50  (11.743)
Hour 13 -5.57  (12.269) -5.01  (13.670) -6.04  (12.832)
Hour 14 -6.18  (12.291) -5.91  (12.409) -5.26  (12.249)
Hour 15 -7.29  (12.351) -5.95  (11.443) -7.52  (12.395)
Hour 16 -7.68  (12.231) -7.26  (10.726) -6.96  (11.524)
Hour 17 -7.28  (12.097) -7.84  (11.479) -6.14  (12.302)
Hour 18 -8.38  (11.421) -8.81  (10.385) -5.28  (12.401)
Hour 19 -9.02  (11.661) -8.77  (10.560) -5.20  (11.211)
Hour 20 -8.92  (11.687) -7.12  (10.020) -5.80  (11.234)
Hour 21 -8.05  (10.480) -7.24  (12.056) -6.49  (12.078)
Hour 22 -7.16  (10.060) -6.55  (8.317) -5.65  (11.711)
Hour 23 -6.34  (10.752) -5.19  (11.593) -6.26  (9.552)
Hour 24 -5.86  (9.930) -6.05  (9.926) -4.96  (9.716)
10.Secondary Outcome
Title Number of Patients Achieving Successful Blood Pressure Control
Hide Description Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 477 469 481
Measure Type: Number
Unit of Measure: Number of participants
256 270 235
11.Secondary Outcome
Title Change From Baseline in Ambulatory Pulse Pressure
Hide Description Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 188 184 182
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-5.78  (0.23) -5.98  (0.23) -4.58  (0.23)
12.Secondary Outcome
Title Number of Responders
Hide Description 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)
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 477 469 481
Measure Type: Number
Unit of Measure: Participants
312 314 290
13.Secondary Outcome
Title Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
Hide Description Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
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.
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.
Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Overall Number of Participants Analyzed 478 472 484
Measure Type: Number
Unit of Measure: Participants
Adverse events (non-serious and serious 143 132 134
Serious adverse events 5 3 6
Deaths 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description 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 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. Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
All-Cause Mortality
LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/478 (1.05%)   3/472 (0.64%)   6/484 (1.24%) 
Cardiac disorders       
ACUTE CORONARY SYNDROME  1  0/478 (0.00%)  0/472 (0.00%)  1/484 (0.21%) 
ANGINA PECTORIS  1  0/478 (0.00%)  0/472 (0.00%)  1/484 (0.21%) 
ATRIAL FIBRILLATION  1  0/478 (0.00%)  0/472 (0.00%)  1/484 (0.21%) 
Hepatobiliary disorders       
BILE DUCT STONE  1  1/478 (0.21%)  0/472 (0.00%)  0/484 (0.00%) 
CHOLELITHIASIS  1  1/478 (0.21%)  0/472 (0.00%)  0/484 (0.00%) 
Infections and infestations       
DENGUE FEVER  1  0/478 (0.00%)  0/472 (0.00%)  1/484 (0.21%) 
GASTROENTERITIS  1  0/478 (0.00%)  1/472 (0.21%)  0/484 (0.00%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  1/478 (0.21%)  0/472 (0.00%)  0/484 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/478 (0.21%)  0/472 (0.00%)  0/484 (0.00%) 
BLOOD BILIRUBIN INCREASED  1  0/478 (0.00%)  0/472 (0.00%)  1/484 (0.21%) 
Musculoskeletal and connective tissue disorders       
SPINAL OSTEOARTHRITIS  1  0/478 (0.00%)  1/472 (0.21%)  0/484 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
THYROID NEOPLASM  1  0/478 (0.00%)  1/472 (0.21%)  0/484 (0.00%) 
Renal and urinary disorders       
CALCULUS URETERIC  1  1/478 (0.21%)  0/472 (0.00%)  0/484 (0.00%) 
Skin and subcutaneous tissue disorders       
PRURITUS  1  1/478 (0.21%)  0/472 (0.00%)  0/484 (0.00%) 
Vascular disorders       
HYPERTENSION  1  0/478 (0.00%)  0/472 (0.00%)  1/484 (0.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/478 (13.81%)   63/472 (13.35%)   66/484 (13.64%) 
Infections and infestations       
UPPER RESPIRATORY TRACT INFECTION  1  15/478 (3.14%)  5/472 (1.06%)  8/484 (1.65%) 
Investigations       
BLOOD GLUCOSE INCREASED  1  5/478 (1.05%)  10/472 (2.12%)  13/484 (2.69%) 
Metabolism and nutrition disorders       
HYPERLIPIDAEMIA  1  16/478 (3.35%)  22/472 (4.66%)  21/484 (4.34%) 
HYPERURICAEMIA  1  14/478 (2.93%)  13/472 (2.75%)  16/484 (3.31%) 
Nervous system disorders       
DIZZINESS  1  8/478 (1.67%)  11/472 (2.33%)  3/484 (0.62%) 
HEADACHE  1  6/478 (1.26%)  4/472 (0.85%)  10/484 (2.07%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  11/478 (2.30%)  5/472 (1.06%)  3/484 (0.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
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: NCT01785472     History of Changes
Other Study ID Numbers: CLCZ696A2315
CLCZ696A2315 ( Other Identifier: Novartis )
First Submitted: February 5, 2013
First Posted: February 7, 2013
Results First Submitted: August 6, 2015
Results First Posted: September 4, 2015
Last Update Posted: December 29, 2016