Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01876368
• Collaborator: (none)
• Enrollment: 376
• Locations: 51
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 376 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LCZ696 200 mg Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Drug: LCZ696; Drug: Placebo of LCZ696
Active Comparator: Olmesartan 20 mg Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.	Drug: Olmesartan; Drug: Placebo of Olmesartan

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) [baseline, 8 weeks]

   Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.

Secondary Outcome Measures

1. Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) [baseline, 8 weeks]

   Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.

2. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [baseline, 8 weeks]

   Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean

3. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [baseline, 8 weeks]

   Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean

4. Change From Baseline in Office Pulse Pressure [baseline, 8 weeks]

   Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.

5. Number of Patients Achieving Successful Overall Blood Pressure Control [8 weeks]

   Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg

6. Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control [8 weeks]

   Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg

7. Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control [8 weeks]

   Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg

8. Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response [baseline, 8 weeks]

   Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.

9. Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response [baseline, 8 weeks]

   Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.

10. Number of Patients With Total Adverse Events, Serious Adverse Events and Death [8 weeks]

    Number of patients with total adverse events, serious adverse events and death were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy

• treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch

• untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch

• patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion Criteria:

• Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)

• History of angioedema, drug-related or otherwise

• History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease (PKD), drug-induced hypertension

• Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Birmingham	Alabama	United States	35294-2041
2	Novartis Investigative Site	Fair Oaks	California	United States	95628
3	Novartis Investigative Site	Hawaiian Gardens	California	United States	90716
4	Novartis Investigative Site	Long Beach	California	United States	90806
5	Novartis Investigative Site	Los Angeles	California	United States	90057
6	Novartis Investigative Site	Orangevale	California	United States	95662
7	Novartis Investigative Site	Westlake Village	California	United States	91361
8	Novartis Investigative Site	Denver	Colorado	United States	80206
9	Novartis Investigative Site	Atlanta	Georgia	United States	30308
10	Novartis Investigative Site	Conyers	Georgia	United States	30094
11	Novartis Investigative Site	Chicago	Illinois	United States	60607
12	Novartis Investigative Site	Chicago	Illinois	United States	60610
13	Novartis Investigative Site	Topeka	Kansas	United States	66606
14	Novartis Investigative Site	Edina	Minnesota	United States	55435
15	Novartis Investigative Site	Belzoni	Mississippi	United States	39038
16	Novartis Investigative Site	Jackson	Mississippi	United States	39209
17	Novartis Investigative Site	New York	New York	United States	10708
18	Novartis Investigative Site	Cincinnati	Ohio	United States	45246
19	Novartis Investigative Site	Oregon City	Oregon	United States	97045
20	Novartis Investigative Site	Portland	Oregon	United States	97225
21	Novartis Investigative Site	Varnville	South Carolina	United States	29944
22	Novartis Investigative Site	Richmond	Virginia	United States	23294
23	Novartis Investigative Site	Caba	Buenos Aires	Argentina	C1429BWN
24	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires	Argentina	C1119ACN
25	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires	Argentina	C1430AAQ
26	Novartis Investigative Site	Caba	Capital Federal	Argentina	C1425FVH
27	Novartis Investigative Site	Posadas	Misiones	Argentina	N3300AHX
28	Novartis Investigative Site	Buenos aires		Argentina	C1120AAC
29	Novartis Investigative Site	Corrientes		Argentina	W3400
30	Novartis Investigative Site	Guatemala City		Guatemala	01001
31	Novartis Investigative Site	Guatemala City		Guatemala	01010
32	Novartis Investigative Site	Quezon City	Manila	Philippines	1100
33	Novartis Investigative Site	Manila	Metro Manila	Philippines	1000
34	Novartis Investigative Site	Quezon City		Philippines	1100
35	Novartis Investigative Site	Quezon City		Philippines	1102
36	Novartis Investigative Site	Manati		Puerto Rico	00674
37	Novartis Investigative Site	Ponce		Puerto Rico	00716
38	Novartis Investigative Site	Ponce		Puerto Rico	00717
39	Novartis Investigative Site	Moscow		Russian Federation	101990
40	Novartis Investigative Site	Moscow		Russian Federation	111539
41	Novartis Investigative Site	Moscow		Russian Federation	117198
42	Novartis Investigative Site	Moscow		Russian Federation	129301
43	Novartis Investigative Site	Saint Petersburg		Russian Federation	199106
44	Novartis Investigative Site	Saratov		Russian Federation	410012
45	Novartis Investigative Site	St.- Petersburg		Russian Federation	197110
46	Novartis Investigative Site	Sevilla	Andalucia	Spain	41009
47	Novartis Investigative Site	Centelles	Cataluña	Spain	08540
48	Novartis Investigative Site	Hostalets de Balenya	Cataluña	Spain	08550
49	Novartis Investigative Site	Alzira	Comunidad Valenciana	Spain	46600
50	Novartis Investigative Site	Santiago de Compostela	Galicia	Spain	15706
51	Novartis Investigative Site	Madrid		Spain	28046

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: NCT01876368
• Other Study ID Numbers: CLCZ696A2318; 2013-001783-36
• First Posted: Jun 12, 2013
• Last Update Posted: Dec 7, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Novartis Pharmaceuticals: hypertension,; LCZ696,; olmesartan
• Additional relevant MeSH terms: Hypertension; Olmesartan; Olmesartan Medoxomil; Sacubitril and valsartan sodium hydrate drug combination

Study Results

Participant Flow

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Period Title: Overall Study
STARTED	188	188
Full Analysis Set (FAS)	188	187
Safety Set (SAF)	188	187
COMPLETED	179	175
NOT COMPLETED	9	13

Baseline Characteristics

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg	Total
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.	Total of all reporting groups
Overall Participants	188	187	375
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.1 (10.19)	58.0 (9.09)	57.6 (9.65)
Sex: Female, Male (Count of Participants)
Female	91 48.4%	92 49.2%	183 48.8%
Male	97 51.6%	95 50.8%	192 51.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
Description	Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	167	164
Least Squares Mean (Standard Error) [mmHg]	-4.26 (0.60)	-1.04 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LCZ696 200 mg, Olmesartan 20 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.19
	Confidence Interval	(2-Sided) 95%; -4.73 to -1.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.78
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)
Description	Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	167	164
Least Squares Mean (Standard Error) [mmHg]	-2.27 (0.39)	-0.35 (0.39)

3. Secondary Outcome

Title	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Description	Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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.

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Least Squares Mean (Standard Error) [mmHg]	-14.21 (1.28)	-10.03 (1.29)

4. Secondary Outcome

Title	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Description	Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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.

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Least Squares Mean (Standard Error) [mmHg]	-7.52 (0.70)	-4.47 (0.71)

5. Secondary Outcome

Title	Change From Baseline in Office Pulse Pressure
Description	Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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.

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Least Squares Mean (Standard Error) [mmHg]	-6.67 (0.94)	-5.54 (0.94)

6. Secondary Outcome

Title	Number of Patients Achieving Successful Overall Blood Pressure Control
Description	Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Number [Participants]	76 40.4%	52 27.8%

7. Secondary Outcome

Title	Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
Description	Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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.

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Number [Participants]	84 44.7%	58 31%

8. Secondary Outcome

Title	Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
Description	Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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.

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Number [Participants]	133 70.7%	112 59.9%

9. Secondary Outcome

Title	Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
Description	Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Number [Participants]	90 47.9%	65 34.8%

10. Secondary Outcome

Title	Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
Description	Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, 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

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Number [Participants]	137 72.9%	115 61.5%

11. Secondary Outcome

Title	Number of Patients With Total Adverse Events, Serious Adverse Events and Death
Description	Number of patients with total adverse events, serious adverse events and death were reported.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization.

Arm/Group Title	LCZ696 200 mg	Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Measure Participants	188	187
Adverse events (serious and non-serious)	44 23.4%	41 21.9%
Serious Adverse Events	0 0%	2 1.1%
Deaths	0 0%	0 0%

Adverse Events

Arm/Group Title	LCZ696 200 mg		Olmesartan 20 mg
Arm/Group Description	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.		Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
All Cause Mortality
	LCZ696 200 mg		Olmesartan 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LCZ696 200 mg		Olmesartan 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/188 (0%)		2/187 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF THYROID GLAND	0/188 (0%)		1/187 (0.5%)
Nervous system disorders
CEREBROVASCULAR ACCIDENT	0/188 (0%)		1/187 (0.5%)
Other (Not Including Serious) Adverse Events
	LCZ696 200 mg		Olmesartan 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/188 (3.7%)		10/187 (5.3%)
Nervous system disorders
DIZZINESS	2/188 (1.1%)		4/187 (2.1%)
HEADACHE	5/188 (2.7%)		6/187 (3.2%)

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.