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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01615198
• Collaborator: (none)
• Enrollment: 588
• Locations: 78
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Olmesartan; Drug: Placebo; Drug: LCZ696	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 588 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Placebo; Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule; Drug: LCZ696; 100 mg, 200 mg tablets
Active Comparator: 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.	Drug: Olmesartan; 10 mg, 20 mg, 40 mg capsules; Drug: Placebo; Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [Baseline, 10 weeks]

   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.

Secondary Outcome Measures

1. Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) [Baseline, 10 weeks]

   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.

2. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) [Baseline, 4 weeks, 14 weeks]

   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.

3. Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) [Baseline, 10 weeks]

   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.

4. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [Baseline, 10 weeks]

   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.

5. Change From Baseline in Mean Sitting Pulse Pressure [Baseline, 4 weeks, 10 weeks, 14 weeks]

   Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.

6. Change From Baseline in Daytime and Nighttime maSBP/maDBP [Baseline, 10 weeks]

   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.

7. Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers [Baseline, 10 weeks]

   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.

8. Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers [Baseline, 10 weeks]

   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.

9. Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) [4 weeks, 10 weeks, 14 weeks]

   A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.

10. Number of Participants Achieving Successful Response in msSBP and msDBP [4 weeks,10 weeks, 14 weeks]

    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.

11. Number of Participants With Adverse Events, Serious Adverse Events and Death [14 weeks]

    Adverse event monitoring was conducted throughout the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must give written informed consent before any assessment is performed

• Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg

• Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

Exclusion criteria:

• Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise

• Patients with history or evidence of a secondary form of hypertension

• Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke

• History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.

• Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).

• Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication

• Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).

• Patients with a clinically significant valvular heart disease at the time of screening

• Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Chongqing	Chongqing	China	400042
2	Novartis Investigative Site	Changsha	Hunan	China	410003
3	Novartis Investigative Site	Suzhou	Jiangsu	China	215006
4	Novartis Investigative Site	Shenyang	Liaoning	China	110003
5	Novartis Investigative Site	Xi'an	Shanxi	China	710061
6	Novartis Investigative Site	Hangzhou	Zhejiang	China	310006
7	Novartis Investigative Site	Hangzhou	Zhejiang	China	310013
8	Novartis Investigative Site	Beijing		China	100020
9	Novartis Investigative Site	Shanghai		China	200025
10	Novartis Investigative Site	Tianjin		China	300142
11	Novartis Investigative Site	Hong Kong	Shatin, NT	Hong Kong
12	Novartis Investigative Site	Hong Kong		Hong Kong
13	Novartis Investigative Site	Toon-city	Ehime	Japan	791-0295
14	Novartis Investigative Site	Chikushi-gun	Fukuoka	Japan	811-1244
15	Novartis Investigative Site	Fukuoka-city	Fukuoka	Japan	810-0066
16	Novartis Investigative Site	Kitakyushu-city	Fukuoka	Japan	807-0856
17	Novartis Investigative Site	Asahikawa	Hokkaido	Japan	078-8214
18	Novartis Investigative Site	Sapporo-city	Hokkaido	Japan	062-0053
19	Novartis Investigative Site	Sapporo-city	Hokkaido	Japan	063-0842
20	Novartis Investigative Site	Sapporo	Hokkaido	Japan	003-0026
21	Novartis Investigative Site	Sapporo	Hokkaido	Japan	003-0825
22	Novartis Investigative Site	Kawasaki-city	Kanagawa	Japan	210-0852
23	Novartis Investigative Site	Kyotanabe-city	Kyoto	Japan	610-0361
24	Novartis Investigative Site	Kyoto-city	Kyoto	Japan	615-8125
25	Novartis Investigative Site	Suita-city	Osaka	Japan	565-0871
26	Novartis Investigative Site	Toyonaka-city	Osaka	Japan	560-0082
27	Novartis Investigative Site	Fujimino	Saitama	Japan	356-0053
28	Novartis Investigative Site	Hiki-Gun	Saitama	Japan	355-0328
29	Novartis Investigative Site	Koshigaya city	Saitama	Japan	343-0826
30	Novartis Investigative Site	Tokorozawa-city	Saitama	Japan	359-1161
31	Novartis Investigative Site	Edogawa-ku	Tokyo	Japan	133-0061
32	Novartis Investigative Site	Edogawa-ku	Tokyo	Japan	134-0084
33	Novartis Investigative Site	Hachioji-city	Tokyo	Japan	192-0918
34	Novartis Investigative Site	Hachioji	Tokyo	Japan	192-0046
35	Novartis Investigative Site	Katsushika-ku	Tokyo	Japan	124-0024
36	Novartis Investigative Site	Kiyose-city	Tokyo	Japan	204-0021
37	Novartis Investigative Site	Kunitachi	Tokyo	Japan	186-0001
38	Novartis Investigative Site	Meguro-ku	Tokyo	Japan	152-0031
39	Novartis Investigative Site	Minato-ku	Tokyo	Japan	105-7390
40	Novartis Investigative Site	Minato-ku	Tokyo	Japan	108-0075
41	Novartis Investigative Site	Shibuya-ku	Tokyo	Japan	150-0002
42	Novartis Investigative Site	Shinagawa-ku	Tokyo	Japan	141-0032
43	Novartis Investigative Site	Tachikawa	Tokyo	Japan	190-0013
44	Novartis Investigative Site	Taito	Tokyo	Japan	111-0052
45	Novartis Investigative Site	Toshima-ku	Tokyo	Japan	171-0021
46	Novartis Investigative Site	Osaka		Japan	560-0005
47	Novartis Investigative Site	Saitama		Japan	337-0012
48	Novartis Investigative Site	Bucheon	Gyeonggi-do	Korea, Republic of	424-717
49	Novartis Investigative Site	Goyang	Gyeonggi-do	Korea, Republic of	412-270
50	Novartis Investigative Site	Seongnam	Gyeonggi	Korea, Republic of	463-707
51	Novartis Investigative Site	Jeonju-si	Jeollabuk-do	Korea, Republic of	561-712
52	Novartis Investigative Site	Koyang	Kyunggi	Korea, Republic of	410-719
53	Novartis Investigative Site	Daegu		Korea, Republic of	700-712
54	Novartis Investigative Site	Daejeon		Korea, Republic of	302-241
55	Novartis Investigative Site	Incheon		Korea, Republic of	22332
56	Novartis Investigative Site	Incheon		Korea, Republic of	403-720
57	Novartis Investigative Site	Seoul		Korea, Republic of	100-380
58	Novartis Investigative Site	Seoul		Korea, Republic of	134-727
59	Novartis Investigative Site	Seoul		Korea, Republic of	135-720
60	Novartis Investigative Site	Seoul		Korea, Republic of	150-713
61	Novartis Investigative Site	Seoul		Korea, Republic of	150-950
62	Novartis Investigative Site	Seoul		Korea, Republic of	152-703
63	Novartis Investigative Site	Quezon City	Manila	Philippines	1100
64	Novartis Investigative Site	Manila	Metro Manila	Philippines	1000
65	Novartis Investigative Site	Quezon City		Philippines	1100
66	Novartis Investigative Site	Quezon City		Philippines	1102
67	Novartis Investigative Site	Valenzuela City		Philippines	1441
68	Novartis Investigative Site	Taichung	Taiwan ROC	Taiwan	40201
69	Novartis Investigative Site	Taipei	Taiwan, ROC	Taiwan	112
70	Novartis Investigative Site	Changhua		Taiwan	500
71	Novartis Investigative Site	Kaohsiung		Taiwan	807
72	Novartis Investigative Site	Taichung		Taiwan	40447
73	Novartis Investigative Site	Taipei		Taiwan	10002
74	Novartis Investigative Site	Taipei		Taiwan	114
75	Novartis Investigative Site	Taipei		Taiwan
76	Novartis Investigative Site	Bangkok		Thailand	10400
77	Novartis Investigative Site	Bangkok		Thailand	10700
78	Novartis Investigative Site	Chiang Mai		Thailand	50200

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01615198
• Other Study ID Numbers: CLCZ696A2316
• First Posted: Jun 8, 2012
• Last Update Posted: Oct 23, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Novartis Pharmaceuticals: Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Olmesartan; Sacubitril and valsartan sodium hydrate drug combination

Study Results

Participant Flow

Arm/Group Title	LCZ696	Olmesartan
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

Baseline Characteristics

Arm/Group Title	LCZ696	Olmesartan	Total
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 Participants	296	292	588
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.5 (4.67)	70.9 (4.67)	70.7 (4.67)
Sex: Female, Male (Count of Participants)
Female	154 52%	140 47.9%	294 50%
Male	142 48%	152 52.1%	294 50%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
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

Outcome Measure Data

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
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.
Measure Participants	295	291
Least Squares Mean (Standard Error) [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)
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

Outcome Measure Data

Analysis Population Description

A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.

Arm/Group Title	LCZ696	Olmesartan
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.
Measure Participants	154	157
Least Squares Mean (Standard Error) [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)
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

Outcome Measure Data

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
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.
Measure Participants	295	291
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)
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

Outcome Measure Data

Analysis Population Description

A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.

Arm/Group Title	LCZ696	Olmesartan
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.
Measure Participants	154	157
Least Squares Mean (Standard Error) [mmHg]	-6.95 (0.31)	-4.47 (0.31)

5. Secondary Outcome

Title	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
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

Outcome Measure Data

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
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.
Measure Participants	295	291
Least Squares Mean (Standard Error) [mmHg]	-8.58 (0.47)	-6.49 (0.48)

6. Secondary Outcome

Title	Change From Baseline in Mean Sitting Pulse Pressure
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

Outcome Measure Data

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
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.
Measure Participants	295	291
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
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

Outcome Measure Data

Analysis Population Description

A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.

Arm/Group Title	LCZ696	Olmesartan
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.
Measure Participants	154	157
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
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

Outcome Measure Data

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
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.
Measure Participants	82	84
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
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

Outcome Measure Data

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
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.
Measure Participants	123	116
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)
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

Outcome Measure Data

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
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.
Measure Participants	295	291
4 weeks	140 47.3%	120 41.1%
10 weeks	175 59.1%	130 44.5%
14 weeks	173 58.4%	126 43.2%

11. Secondary Outcome

Title	Number of Participants Achieving Successful Response in msSBP and msDBP
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

Outcome Measure Data

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
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.
Measure Participants	295	291
msSBP, week 4	162 54.7%	146 50%
msSBP, week 10	208 70.3%	142 48.6%
msSBP, week 14	205 69.3%	144 49.3%
msDBP, week 4	264 89.2%	245 83.9%
msDBP, week 10	275 92.9%	254 87%
msDBP, week 14	268 90.5%	246 84.2%

12. Secondary Outcome

Title	Number of Participants With Adverse Events, Serious Adverse Events and Death
Description	Adverse event monitoring was conducted throughout the study.
Time Frame	14 weeks

Outcome Measure Data

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
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.
Measure Participants	296	292
Adverse events (non-serious and serious)	141 47.6%	113 38.7%
Serious adverse events	7 2.4%	2 0.7%
Deaths	0 0%	0 0%

Adverse Events

Arm/Group Title	LCZ696		Olmesartan
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LCZ696		Olmesartan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/296 (2.4%)		2/292 (0.7%)
Cardiac disorders
ARRHYTHMIA	1/296 (0.3%)		0/292 (0%)
ATRIAL FIBRILLATION	1/296 (0.3%)		0/292 (0%)
Ear and labyrinth disorders
VERTIGO	1/296 (0.3%)		0/292 (0%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED	1/296 (0.3%)		0/292 (0%)
ASPARTATE AMINOTRANSFERASE INCREASED	1/296 (0.3%)		0/292 (0%)
LIVER FUNCTION TEST ABNORMAL	0/296 (0%)		1/292 (0.3%)
Musculoskeletal and connective tissue disorders
MUSCLE ATROPHY	1/296 (0.3%)		0/292 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA	1/296 (0.3%)		0/292 (0%)
Nervous system disorders
CEREBRAL INFARCTION	1/296 (0.3%)		0/292 (0%)
Renal and urinary disorders
HENOCH-SCHONLEIN PURPURA NEPHRITIS	0/296 (0%)		1/292 (0.3%)
Other (Not Including Serious) Adverse Events
	LCZ696		Olmesartan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/296 (16.6%)		44/292 (15.1%)
Infections and infestations
NASOPHARYNGITIS	24/296 (8.1%)		18/292 (6.2%)
UPPER RESPIRATORY TRACT INFECTION	10/296 (3.4%)		6/292 (2.1%)
Metabolism and nutrition disorders
HYPERURICAEMIA	11/296 (3.7%)		19/292 (6.5%)
Nervous system disorders
DIZZINESS	6/296 (2%)		2/292 (0.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.